JKPK (JURNAL KIMIA DAN PENDIDIKAN KIMIA).
Vol.
No.
1, 2024
Chemistry Education Study Program.
Universitas Sebelas Maret https://jurnal.
id/jkpk ISSN 2503-4146 ISSN 2503-4154 .
SIMULTANEOUS DETERMINATION OF ISONIAZID AND PYRIDOXINE HYDROCHLORIDE IN TABLET DOSAGE FORMS
USING RATIO SUBTRACTION SPECTROPHOTOMETRY
Rida Evalina Tarigan 1,*.
Ester Lince Fiani Mendrofa 1.
Chemayanti Surbakti 2 Departement of Pharmaceutical Chemistry.
Faculty of Pharmacy and Health.
Institut Kesehatan Helvetia.
Medan.
Indonesia Departement of Pharmaceutical Chemistry.
Faculty of Pharmacy.
Universitas Sumatera Utara.
Medan.
Indonesia
ARTICLE INFO
ABSTRACT
Keywords:
Isoniazid.
pyridoxine hydrochloride.
ratio subtraction.
Article History:
Received: 2023-08-21 Accepted: 2024-01-03 Published: 2024-27-02 *Corresponding Author Email:
ridaevalinatarigan@helvetia.
doi:10.
20961/jkpk.
A 2024 The Authors.
This open-access distributed under a (CC-BY-SA Licens.
The study focused on the simultaneous quantification of Isoniazid (INH) and Pyridoxine Hydrochloride (PRD) in tablet form, commonly used in antituberculosis treatments.
Assessing the accurate concentration of both INH and PRD in tablets is vital to ensure their effectiveness, safety, and quality.
Using the ratio subtraction spectrophotometry method, the study analyzed INH and PRD in Pehadoxin forteA tablets .
atch no.
PT.
Phapros.
Indonesi.
, with 0.
1 N HCl as the solvent.
The method involved obtaining ratio absorption spectra by dividing the absorption spectra of INH and PRD, respectively, to derive zero-order spectra for each drug.
Method validation parameters included linearity, accuracy, precision.
Limit of Detection (LOD), and Limit of Quantification (LOQ).
The results showed linearity values of 0.
9985 for INH and 0.
for PRD.
Accuracy was 98.
1838% for INH and 100.
0205% for PRD, while precision was 1.
8769% for INH and 0.
2037% for PRD.
LOD and LOQ for INH were 0.
8116 AAg/mL and 2.
7053 AAg/mL, respectively, and for PRD, 3127 AAg/mL and 4.
3757 AAg/mL.
The levels of INH and PRD in the tablets were found to be 102.
1157% and 101.
3874%, aligning with the Indonesian Pharmacopoeia's standards.
This methodological approach provides a reliable analytical tool for the simultaneous assessment of INH and PRD in tablets, potentially extendable to other drug combinations and formulations, thereby contributing to pharmaceutical quality control How to cite: R.
Tarigan.
Mendrofa.
Surbakti, " Simultaneous Determination of Isoniazid and Pyridoxine Hydrochloride in Tablet Dosage form by Ratio Subtraction Spectrophotometry" JKPK (Jurnal Kimia dan Pendidikan Kimi.
, vol.
9, no.
1, pp.
1 -14, 2024.
http://dx.
org/10.
20961/jkpk.
eventual death of the bacterial cell wall, with INTRODUCTION
Isoniazid
(INH)
Pyridoxine form, are key medications in the treatment of therapies prevents the development of drug- tuberculosis (TB).
INH's effectiveness stems resistant strains, and as a prophylactic, it from its unique action mechanism, inhibiting helps control the spread of TB.
The INH the enzyme enoyl acyl carrier protein mechanism disrupts a critical bacterial reductase (InhA), crucial for mycolic acid process, enhancing its efficacy in TB biosynthesis in Mycobacterium tuberculosis.
This inhibition leads to the weakening and administration can reduce the risk of Hydrochloride (PRD), available in tablet Its Concurrently.
PRD peripheral neuropathy, a common side effect Tarigan et al, " Simultaneous Determination of Isoniazid a.
of INH.
PRD's primary function is to replenish low technique, is valuable for analyzing multiple levels of the active vitamin B6 coenzyme, separation, even with overlapping adjacent neuroprotective activity essential for maintaining This method is convenient for nerve function and alleviating symptoms caused by INH-induced peripheral neuropathy .
derivatization, offering practicality and accuracy.
Determining drug levels is critical in It's efficient, needing minimal preparation time, monographs .
uality standard.
to ensure drug fewer solvents, and straightforward mathematical The ratio subtraction approach assessment, as stipulated in monographs, is presents a significant alternative to traditional essential for ensuring that each drug dose spectrophotometric methods, especially when contains the correct amount of active ingredient.
enhanced selectivity and sensitivity are required This is pivotal for maintaining drug stability and .
Accurate efficacy, as incorrect dosages could lead to INH
PRD
adverse reactions or suboptimal therapeutic spectrophotometric analysis due to conjugated outcomes .
Various methods like HPLC, double bonds, chromophores, and auxochromes voltammetry.
HPTLC, spectrophotometry, and in their structures, facilitating light absorption at ultra-fast liquid chromatography are utilized to specific wavelengths.
This property allows for the quantitative analysis of these compounds .
, individually or in combination.
Each method has The rationale for employing ratio subtraction its drawbacks.
for instance.
HPLC and HPTLC are costlier .
, .
, voltammetry's sensitivity determination of INH and PRD in tablet form lies .
, in addressing the unique analytical challenges associated with conventional spectrophotometric skewed by interfering substances .
, and Potential benefits include improved ultra-fast liquid chromatography is also expensive selectivity, sensitivity, and adaptability to complex .
The choice of analytical method hinges on This makes it a promising technique specific requirements like sensitivity, selectivity, for concurrent analyses.
This study aimed to and cost.
In this context, the ratio subtraction spectrophotometry method is favored for its measuring INH and PRD in tablet dosage forms selectivity and cost-effectiveness .
INH
The PRD (PRD) in tablet preparations is critical for ensuring process provides a detailed understanding of the drug composition, facilitating accurate dosing, treatment success, and improved patient safety in managing tuberculosis and related conditions.
METHODS
Materials:
the medications' efficacy, safety, and quality.
This Isoniazid (INH) and Pyridoxine Hydrochloride Ratio The study utilized high-quality raw materials of Isoniazid (INH) and Pyrazinamide (PRD), sourced from the Indonesian Food and Drug Monitoring Agency, authenticity and purity of the compounds.
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Hydrochloric acid (HC.
supplied by Merck at a 1 N HCl within a 50-mL volumetric flask, concentration of 0.
1 N was used as a solvent to resulting in a 1000 AAg/mL stock solution.
Subsequently, 2.
5 mL of this stock solution was Pehadoxin diluted in a 25 mL volumetric flask to prepare a tablets, each containing 400 mg of INH and 10 mg working solution with a 100 AAg/mL concentration of PRD, were chosen for the analysis.
suitable for the subsequent analytical procedures.
manufactured these tablets.
Phapros Indonesia Preparation of INH Absorption Spectra:
Additionally, provides a practical sample for testing the To analyze Isoniazid (INH), various analytical method in a real-world pharmaceutical solutions with varying concentrations were prepared, specifically from 5 AAg/mL to 15 AAg/mL.
Equipment:
These The analytical procedures were carried out using state-of-the-art equipment.
A Shimadzu absorption spectra were recorded across a Ultraviolet-visible wavelength range of 200-400 nm.
This step is renowned for its precision and reliability in critical for identifying the characteristic absorption spectrophotometric analysis, was employed for peaks of INH and establishing a baseline for measuring the absorbance of the samples.
This further analysis.
spectrophotometer was connected to a computer Preparation of PRD Absorption Spectra:
equipped with UV-Probe 2.
43 UV-1800 software, were prepared with concentrations ranging from 6 Additionally, a highly accurate analytical balance AAg/mL to 18 AAg/mL.
The absorption spectra of from Sartorius.
Gottingen.
Germany, was used to these solutions were also measured over the 200- 400 nm wavelength range.
The spectra obtained Similarly.
Pyrazinamide (PRD) solutions measurement of the compounds.
provide essential data for distinguishing the Preparation of INH Standard Solution:
unique absorption characteristics of PRD.
The standard solution of INH was prepared by accurately weighing 50 mg of the Preparation of Mixed Spectra of INH and PRD:
com pound and dissolving it in a 50-mL volumetric This step involved the preparation of a flask with 0.
1 N HCl, yielding a stock solution with solution containing both INH and PRD, allowing a concentration of 1000 AAg/mL.
A working for the simultaneous spectrophotometric analysis solution was prepared from this stock solution by of both drugs.
The mixed solution's absorption 5 mL in a separate 25 mL volumetric spectrum was then measured, crucial for flask to achieve a 100 AAg/mL concentration.
This understanding how the two drugs interact dilution process was critical for obtaining a spectrally and discerning overlapping absorption spectrophotometric analysis.
Preparation of PRD Standard Solution:
A similar procedure was followed for the INH Analysis via Ratio Subtraction Spec For the analysis of INH, the ratio preparation of the PRD standard solution.
50 mg of PRD was accurately weighed and dissolved in This sophisticated technique involves Tarigan et al, " Simultaneous Determination of Isoniazid a.
dividing the INH absorption spectrum by the PRD 15 AAg/mL, while for PRD, they varied from 6 spectrum .
sed as a diviso.
, then subtracting and AAg/mL to 18 AAg/mL.
The absorbance of these multiplying by the divisor.
This method effectively concentrations was measured, enabling the isolates the INH spectrum from the mixture, calculation of linear regression equations and enabling accurate analysis and quantification.
correlation coefficients.
This step is crucial to The ensure the method produces consistent and overlapping spectral data, facilitating a clearer proportional results over various concentrations.
understanding of INH's spectral characteristics Accuracy:
and concentration in the presence of PRD.
Accuracy was assessed by adding PRD Analysis via Ratio Subtraction Spec known quantities of standards to the sample Three different concentrations of the For the Pyrazinamide (PRD) analysis, analytes .
%, 100%, and 120%) were prepared, the ratio subtraction spectrophotometry technique each containing 70% of the analyte and 30% of was similarly employed, but this time using the the standard.
This approach helps verify whether Isoniazid (INH) absorption spectrum as the the method can accurately measure the true The method involves a series of value of the analyte concentrations .
, .
mathematical operations on the PRD spectrum.
Precision:
using the INH spectrum as a reference, to PRD The precision of the method, an indicator of the reproducibility of the results, was component in the mixture.
This precise analytical approach aids in distinguishing the individual deviation (RSD).
A method is considered precise spectral characteristics of PRD, even in the if the RSD is less than 2% .
This low RSD presence of INH.
value indicates that repeated measurements Analysis of Tablet Dosage Form:
under unchanged conditions yield similar results.
To analyze the tablet dosage form Limit of Detection (LOD):
containing INH and PRD, tablets were first The LOD, the smallest concentration of crushed into a fine powder.
An aliquot of this an analyte that can be reliably detected but not powder, equivalent to 400 mg of INH and 10 mg necessarily quantified, was calculated using the of PRD, was then dissolved in 0.
1 N hydrochloric formula: LOD = 3.
3 y .
tandard deviation/slop.
acid (HC.
The resulting solution was subjected .
, .
The LOD is a critical parameter in assessing the sensitivity of the method.
method for quantifying INH and PRD.
This Limit of Quantification (LOQ):
analysis is crucial for verifying the actual content The LOQ of the drugs in tablet form and ensuring concentration of an analyte that can be compliance with pharmaceutical standards.
Method Validation:
precision and accuracy.
It was calculated using Linearity:
LOQ
tandard The study evaluated the linearity of the deviation/slop.
The LOQ is essential for analytical method for both INH and PRD.
determining the minimum concentration level at Concentrations for INH ranged from 5 AAg/mL to which the analyte can be confidently quantified.
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Data Analysis:
RESULTS AND DISCUSSION
The data obtained from the experiments Absorption spectra of INH.
PRD, and mixtures of INH and PRD methods, specifically the t-test.
This analysis The absorption spectra and calibration assessed the statistical significance of the results, curves of INH .
-15 AAg/mL) and PRD .
-18 with a confidence level set at 99%.
Using the t- AAg/mL) measured at 200-400 nm are shown test allows for a rigorous evaluation of the in Figures 1a,b, and 2a,b, respectively, while methodAos the overlapping spectra of the mixture are concentrations of INH and PRD, ensuring that the shown in Figure 3.
findings are statistically valid and reliable.
Absorbance Absorbance Wavelength .
Wavelength .
Figure 1.
INH Absorption Spectrum .
-15 AAg/mL).
INH Calibration Curve .
-15 AAg/mL).
Absorbance Absorbance Concentration (AAg/mL) .
5 Concentration (AAg/mL) .
Figure 2.
PRD Absorption Spectrum .
-18 AAg/mL).
PRD Calibration Curve .
-18 AAg/mL).
Tarigan et al, " Simultaneous Determination of Isoniazid a.
Absorbance Wavelength .
Figure 3.
Spectra Overlap INH .
AAg/mL) and PRD .
AAg/mL) and Mixture (INH 15 AAg/mL and PRD 18 AAg/mL).
Based on Figures 1a and 2a, the ratio subtraction approach, where the initial absorption spectra and calibration curves of divisor is employed in the next step .
, .
INH .
-15 AAg/mL) and PRD .
-18 AAg/mL) INH and PRD Absorption Spectra Using The Ratio Subtraction Spectrophotometry Method measured at 200-400 nm, respectively, comply with Lambert Beer's law .
bsorbance 2Ae0.
, 29, .
Figures 1b and 2b show that the INH regression equation was Y = technique for spectrophotometric analysis, a 0,0390x 0,0120 with correlation coefficients crucial step is the creation of a ratio spectrum.
The PRD regression equation was Y = This process involves selecting an appropriate 0,0355 0,0019, with a correlation coefficient With a value of r O 1, it can be stated influences the accuracy and efficacy of the that the relationship between absorbance and The divisor concentration is chosen concentration is linear .
, meaning the ratio based on the capability to provide the best subtraction spectrophotometry method can be linear regression, ensuring a reliable separation used in this study.
Figure 3 shows that the of overlapping spectral components .
Figures spectral overlap of INH .
AAg/mL).
PRD .
AAg/mL), and mixture (INH 15 AAg/mL and PRD outcomes of this technique using specific 18 AAg/mL) was overcome by using the ratio dividing concentrations for Isoniazid (INH) and subtraction spectrophotometry method .
Pyrazinamide (PRD).
In these figures.
INH and The ratio subtraction approach begins with the PRD were used at concentrations of 15 AAg/mL determination of overlapping spectrum studies.
This analysis of wavelength usage for analysis concentrations were selected as the divisors for indicates that the initial divisor is used for the the ratio spectrum creation.
AAg/mL.
These JKPK (JURNAL KIMIA DAN PENDIDIKAN KIMIA).
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The selection of 15 AAg/mL for INH and can be effectively separated.
This separation is 18 AAg/mL for PRD as dividing concentrations was based on their effectiveness in providing analysis, particularly in complex mixtures clear, distinct spectra after the ratio subtraction where components have closely overlapping The objective was to achieve spectra The application of this method that could be easily interpreted and quantified, which is critical for accurate drug analysis in quantification of each drug component, which is pharmaceutical formulations.
By creating ratio essential for ensuring the quality and efficacy of spectra at these specific concentrations, the pharmaceutical products .
Absorbance overlapping spectral regions of INH and PRD Wavelength .
Absorbance Figure 4.
INH Ratio Spectrum as PRD Divider .
AAg/mL).
Wavelength .
Figure 5.
PRD Ratio Spectrum as INH Divider .
AAg/mL).
Tarigan et al, " Simultaneous Determination of Isoniazid a.
Absorbance Wavelength .
Figure 6.
INH Ratio Spectrum as a PRD Divider of 18 AAg/mL and after reduction with a PRD divider of 18 Absorbance AAg/mL.
Wavelength .
Figure 7.
PRD ratio spectrum as a 15 AAg/mL INH divider and after reduction with a 15 AAg/mL INH Then, these spectra are reduced by ratio subtraction technique, the next step their respective divisors, shown in Figures 6 involves multiplying the obtained spectra by the After creating the ratio spectra using the respective dividers.
This process is crucial for JKPK (JURNAL KIMIA DAN PENDIDIKAN KIMIA).
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converting the ratio spectra back to zero-order original drug compounds in their standard spectra, which are more straightforward to absorption form.
The zero-order spectrum is analyze and quantify.
The zero-order spectrum particularly useful in the quantitative analysis of It allows for the direct correlation of spectrum of a substance where the absorbance absorbance with concentration, following Beer- is directly proportional to the concentration.
Lambert's law.
This makes it possible to Figure 8 illustrates the zero-order INH (Isoniazi.
accurately determine the concentration of INH
PRD
and PRD in a mixture using the absorbance (Pyrazinamid.
obtained through this process.
values obtained from the zero-order spectra.
The spectra result from multiplying the ratio Obtaining zero-order spectra is a critical spectra by their respective dividers, 15 AAg/mL for INH and 18 AAg/mL for PRD.
This spectrophotometry method, enabling precise multiplication effectively reverses the initial ratio and accurate analysis of drug compounds with operation, yielding spectra representative of the overlapping spectra.
Absorbance Wavelength .
Figure 8.
Zero Order Spectrum Of INH and PRD by Subtraction Ratio Method.
The Ratio Subtraction exemplified in the analysis of Isoniazid (INH) Spectrophotometry method, as depicted in and Pyrazinamide (PRD).
The process begins Figures 4-8, represents a systematic approach by dividing the spectrum of the drug mixture by to analyzing drug mixtures, particularly useful a selected divisor concentration.
This step is when dealing with components that have critical as it sets the stage for the subsequent overlapping spectra.
This method applies to a The divisor concentrations for INH wide range of pharmaceutical compounds and and PRD were strategically selected to ensure is crucial for accurately determining the the best possible resolution and distinction concentration of drugs in a mixture, as between the two compounds.
Tarigan et al, " Simultaneous Determination of Isoniazid a.
After the division, the next step is Table 1 summarizes the results of these validation parameters for both INH and PRD.
This step is crucial in isolating each component's spectrum from the mixture.
removes the contribution of the divisor from the spectrum, enabling the identification Table 1.
Method validation Parameter INH
PRD
quantification of the individual components in Linearity the mixture.
Accuracy (%) The final step involves multiplying the Precision (%) subtracted spectrum by the divisor.
This LOD (AAg/mL) multiplication brings the spectrum back to its LOQ (AAg/mL) original scale, but now the overlapping parts are The result of this process is a Table distinct spectrum for each component, free from spectrophotometric subtraction ratio method the interference of the other.
effectively meets the established criteria for Figure 8 is particularly significant, method validation, exhibiting both reliability and presenting this method's INH and PRD zero- accuracy in the analytical assessment of INH order spectra.
This figure illustrates the and PRD.
This method demonstrates a high regression line equations for estimating the concentrations of INH and PRD based on their correlation coefficients for both INH and PRD, respective zero-order spectra.
Specifically.
INH which surpass the threshold of r Ou 0.
995, a is analyzed at a wavelength of 269 nm and PRD standard requirement for method validation at 291 nm.
The concentration of each drug in .
Such linearity is crucial as it ensures a the mixture is then determined by plotting these direct and proportional relationship between the spectra against a calibration curve .
This concentration of the analytes and the measured Ratio Subtraction Spectrophotometry method is response, facilitating accurate quantification.
vital in pharmaceutical analysis as it allows for Regarding accuracy, the method falls the precise quantification of drugs in a mixture, comfortably within the acceptable range of 98- even in cases where their spectra overlap 102% .
This range is essential for ensuring This accuracy is essential for the method consistently yields results that closely align with the true values.
The method's dosage and efficacy .
accuracy is further enhanced by the inclusion of Method Validation standards at defined concentrations of 80%.
The method validation for the analysis 100%, and 120%, each with a composition of of INH (Isoniazi.
and PRD (Pyrazinamid.
includes several crucial parameters: linearity, confirming its capability to measure analyte accuracy, precision.
Limit of Detection (LOD), and Limit of Quantification (LOQ).
These parameters are essential for assessing the Precision, another critical aspect of reliability and efficacy of the analytical method validation, is indicated by the Relative Standard JKPK (JURNAL KIMIA DAN PENDIDIKAN KIMIA).
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Deviation (RSD) values being under 2% .
, with the required standards.
The measured This level of precision signifies the concentration of INH in the tablets was method's consistency and reproducibility under 1157%, and PRD was 101.
These unchanged conditions, which is vital for reliable values fall within the acceptable range of 90.
analytical testing.
The Limit of Detection (LOD) 0% of the amount declared on the label.
and Limit of Quantitation (LOQ) are additional This range is crucial in pharmaceuticals, as it fundamental parameters in method validation.
guarantees the medications' effectiveness and The Maintaining drug concentrations within LOD, concentration of an analyte detectable by the method, and the LOQ, reflecting the lowest therapeutic benefits and prevent potential side concentration at which the analyte can be effects that could result from incorrect dosing.
The successful adherence of INH and accuracy and precision, are within suitable PRD concentrations within this range indicates ranges for INH and PRD .
These values that the manufacturing process of these tablets highlight the method's sensitivity and accuracy is consistent and reliable.
Such precision in in detecting and quantifying low concentrations drug formulation is essential for maintaining the of these compounds, further affirming its standard of care in medical treatments.
The results demonstrate the importance of rigorous pharmaceutical quality control.
quality control in pharmaceutical production INH and PRD Levels in Tablet Dosage Form and underscore the effectiveness of the ratio The levels of INH and PRD in tablets based on the analysis results using the ratio established standards .
subtraction spectrophotometry method are CONCLUSION shown in Table 2.
Table 2.
INH and PRD Levels in Tablet Dosage Form
The spectrophotometry method effectively enables Component Level (%) Requirement (%) INH
PRD
the simultaneous determination of isoniazid (INH) and pyridoxine hydrochloride (PRD) in tablet dosage form.
The absorption spectra analysis of INH and PRD confirmed their The Lambert Beer's spectrophotometry method was employed to determine the concentrations of isoniazid (INH) and pyrazinamide (PRD) in tablet formsAithe validation results, including linearity, accuracy, precision.
LOD, and LOQ, demonstrate the robustness and reliability of the proposed pharmaceutical standards.
According to the method for quantification.
The chosen divisor results presented in Table 2, both INH and PRD concentrations .
AAg/mL for INH and 18 AAg/mL concentrations in the tablet dosage forms align Method Tarigan et al, " Simultaneous Determination of Isoniazid a.
for PRD) in the ratio subtraction approach Prasad.
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effectively overcame spectral overlap and The regression equations derived from the ratio subtraction method provide a mathematical framework for high-precision estimating INH and PRD concentrations.
Meeting the content requirements for both INH and PRD levels in tablet dosage form highlights the applicability and accuracy of the proposed method in pharmaceutical quality control.
The advantages of the ratio subtraction method, including simplicity, accuracy, and practicality, make it a valuable tool for simultaneous quantification of compounds in complex mixtures.
The study's findings contribute to pharmaceutical quality control processes, ensuring tablet formulations meet the required content standards.
The proposed method aligns with the study's research objectives by providing a robust analytical approach for quantifying INH and PRD in tablet preparations.
The developed analytical strategy can be extended to other drug combinations and complex formulations, enhancing its versatility in pharmaceutical ACKNOWLEDGMENT The author would like to thank the Research Laboratory Faculty Pharmacy at the University of North Sumatra in Medan for providing research facilities.
REFERENCES