Simultaneous Determination of Isoniazid and Pyridoxine Hydrochloride in Tablet Dosage Forms using Ratio Subtraction Spectrophotometry
Abstract
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 forte® tablets (batch no. 36057007, PT. Phapros, Indonesia), 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 0.9988 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 µg/mL and 2.7053 µg/mL, respectively, and for PRD, 1.3127 µg/mL and 4.3757 µg/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 processes.
Keywords
Full Text:
PDFReferences
[1] H. Y. Vilchèze, and W. R. Jacobs, “The isoniazid paradigm of killing, resistance, and persistence in mycobacterium tuberculosis,” J.Mol.Biol, vol. 431, no. 18, pp. 3450–3460, 2019.
doi: 10.1016/j.jmb.2019.02.016.
[2] M. S. Prasad, R. P. Bhole, P. B. Khedekar, and R. V. Chikhale, “Mycobacterium enoyl acyl carrier protein reductase (InhA): A key target for antitubercular drug discovery,” Bioor. Chem., vol. 115, p. 105242, 2021,
doi: 10.1016/j.bioorg.2021.105242.
[3] M. Bhargava, and B. Bhargava, “Pyridoxine for patients suffering from drug-susceptible tuberculosis in India,” Public health action, vol. 8, no. 2, pp. 97-97, 2018.
doi: 10.5588/pha.18.0017.
[4] T. Benjamin, and D. Ramachandran, “Development and validation of rp-hplc method for simultaneous estimation of isoniazid and pyridoxine in bulk and its pharmaceutical formulations,” Am. J. Pharm. Tech. Res, vol. 9, no. 1, pp. 215–225, 2019.
doi: 10.46624/ajptr.2019.v9.i1.015.
[5] C. R. Choudhary, J. Kumari, and M. Advani, “Isoniazid induced early-onset of motor dominant neuropathy and treatment with high dose of pyridoxine,” Indian J Tuberc, vol. 65, no. 2, pp. 175–176, 2018,
doi: 10.1016/j.ijtb.2017.04.004.
[6] Departemen Kesehatan Republik Indonesia, “Farmakope Indonesia,” Edisi 6, Kementrian Kesehatan Republik Indonesia. Jakarta, 2020.
[7] S. Umar, T. Saafrida and H. Lucida, “Validasi metode analisis penetapan kadar ketoprofen pada tablet salut enterik secara kromatografi cair kinerja tinggi dan spektrofotometri uv,” JSFK, vol. 8, no. 2, pp. 200–207, 2021.
doi: 10.25077/jsfk.8.2.200-207.2021.
[8] N. F. Atta, A. Galal, and R. A. Ahmed, “Voltammetric Behavior and Determination of Isoniazid Using PEDOT Electrode in the presence of Surface Active Agents,” Int. J. Electrochem. Sci., vol. 6, no. 10, pp. 5097–5113, 2011,
doi: 10.1016/s1452-3981(23)18391-x.
[9] K. Védaste, K. Egide, K. Claver, and E. Kaale, “Development and validation of high-performance thin-layer chromatographic method for the simultaneous determination of rifampicin, isoniazid, and pyrazinamide in a fixed dosage combination tablet,” JPC-J Planar Chromat, vol. 27, no. 5, pp. 392–397, 2014,
doi: 10.1556/jpc.27.2014.5.11.
[10] R. E. Tarigan, and Y. Sarumaha, “Determination isoniazid and pyridoxine hydrochloride levels in tablets with ultraviolet spectrophotometry by successive ratio derivative,” IAMSPH, vol. 3, no. 1, pp. 95–101, 2022.
[11] L. R. Nasution, M. Bachri and E. D. L. Putra, “Simultaneous estimation of isoniazid and pyridoxine hydrochloride levels in tablet dosage form by spectrophotometry ultraviolet with area under curve method,” Asian J. Pharm. Clin. Res, vol. 11, no. 5, pp. 124–126, 2018.
doi: 10.22159/ajpcr.2018.v11i5.24314.
[12] Y. Pratiwi, E. V. Nanda, and A. Kistani, “Effectiveness of Using Zn Powder and Spongy Cadmium As Reductor on Free Nitrite and Nitrate Analysis Method Validation in Bread Samples by UV-Vis Spectrophotometry,” JKPK, vol. 6, no. 3, p. 304, 2021,
doi: 10.20961/jkpk.v6i3.54583.
[13] S. S. Sanjay, S. G. Alegaon and M. S. Palled, “Development and validation of isoniazid in bulk and pharmaceutical dosage forms by uflc method ,” Int. J. Pharma. Res. Health. Sci, vol. 7, no. 1, pp. 2904–2908, 2019.
doi: 10.21276/ijprhs.2019.01.09.
[14] M. M. Sebaiy, “Absorbance Subtraction Method fоr Simultaneous Determination оf Paracetamol and Orphenadrine Citrate in their Combined Pharmaceutical Dosage Forms,” BJSTR, vol. 25, no. 2, 2020,
doi: 10.26717/bjstr.2020.25.004176.
[15] M. Bachri, Masfria, and H. Syahputra, “Quantitative estimation of antihypertension combination by ratio subtraction spectrophotometry method,” Open Acces Maced. J. Med. Sci, vol. 7, no. 17, pp. 2940–2946, 2019.
doi: 10.3889/oamjms.2019.750.
[16] H. Darwish, F. Metwally, and A. El. Bayoumi, “Novel ratio subtraction and isoabsorptive point methods for determination of ambroxol hydrochloride and doxycycline in their combined dosage form: development and validation,” Trop. J. Pharm. Res, vol. 14, no. 1, pp. 133–140, 2015.
doi: 10.4314/tjpr.v14i1.19.
[17] S. M. Riad, M.R. Rezk, G. Y. Mahmoud, and A. A. E. B. A Aleem, “Selective spectrophotometric methods for quantification of sitagliptin and metformin,” Anal. Chem. Indian J, vol. 12, no. 2, pp. 41–47, 2013.
[18] M. Popescu, P. Lancu, V. Plesu, C. S. Bildea, and C. M. Todasca, “Different spectrophotometric method for simultaneous quantification of lycopene and β-carotene from a binary mixture,” LWT Food Science and Technology, vol. 160, pp. 1132–1138, 2022.
doi: 10.1016/j.lwt.2022.113238.
[19] H. W. Darwish, A. H. Bakheit and I. A. Naguib, “Comparative study of novel ratio spectra and isoabsorptive point based spectrophotometric methods: application on a binary mixture of ascorbic acid and rutin,” J Anal Methods Chem, vol. 2016, pp. 1–12, 2016. doi: 10.1155/2016/2828647.
[20] R. E. Tarigan, L. Lutvia and R. M. T. Sitorus, “Development and validation of area under curve spectrophotometry method for binary mixture of paracetamol and ibuprofen in tablet dosage form,” JFI, vol. 19, no. 2, pp. 246–252, 2022. doi: 10.31001/jfi.v19i2.1388
[21] S. Umar, Saafrida and H. Lucida, “Validasi metode analisis penetapan kadar ketoprofen pada tablet salut enterik secara kromatografi cair kinerja tinggi dan spektrofotometri uv,” J. Sains Farm. Klin, vol. 8, no. 2, pp. 200–207, 2021.
doi: 10.25077/jsfk.8.2.200-207.2021.
[22] R. E. Tarigan, Muchlisyam, S. M. Sinaga and Z. Alfian, “Development and validation of double divisior ratio spectra derivative spectrophotometry method for ternary mixture of dextromethorphan hydrobromide, doxylamine succinate and pseudoepherine hydrochloride in tablet dosage form,” Int J Appl Pharm, vol. 12, no. 6, pp. 249–252, 2020. ,
doi: 10.22159/ijap.2020v12i6.39037.
[23] D. Ariyanti and M. Syaifuddin, “Au Extraction from Mineral Rocks with Aeration-Cyanidation Hydrometallurgy and Comparative Study of Its Effectiveness in Various Methods and Solvents,” JKPK, vol. 4, no. 2, pp. 115-122, 2019.
doi: 10.20961/jkpk.v4i2.29020.
[24] R. E. Tarigan, Muchlisyam, S. M. Sinaga and Z. Alfian, “Simultaneous determination of dextromethorphan hydrobromide, doxylamine succinate and pseudoepherine hydrochloride in cough and cold syrup by area under curve spectrophotometry,” Rasayan J. Chem, vol. 14, no. 01, pp. 629–634, 2021.
doi: 10.31788/rjc.2021.1416068.
[25] R. E. Tarigan, D. M. Sianturi and S. Nadya, “Determination of pseudoepherine hydrochloride and triprolidine hydrochloride simultaneously in tablet dosage form,” Rasayan J. Chem, vol. 16, no. 01, pp. 223–226, 2023,
doi: 10.31788/rjc.2023.1618072.
[26] D. Hanwar, D. E. Nitoviani, and A. Suhendi, “Validation of Atomic Absorption Spectrometry Method for Contamination Determination of Lead (Pb) and Cadmium (Cd) in Methanol Extract and Product of Curcuma xanthorrhiza Roxb.,” JKPK, vol. 2, no. 3, p. 198-205, 2018,
doi: 10.20961/jkpk.v2i3.11968.
[27] G. E. Halim, and M. Tjahjono, “Evaluation Of Color Models For Quantitative Determination Of Food Dyes Using Smartphonebased Digital Image Analysis,” JKPK, vol. 8, no. 1, p. 86-100, 2023, doi: 10.20961/jkpk.v8i1.72928.
[28] N. Dali, S. Dali, A. Chairunnas, H. A. M. Amalia, and S. A. A. Puspitasari, “Highly Selective and Sensitive Determination of Hg(II) Ions Using Ion Selective Electrodes (ISE) Coated with the BEC4ND1 Ionophore as Membranes,” JKPK, vol. 7, no. 2, p. 242-254, 2022, doi: 10.20961/jkpk.v7i2.62213.
[29] A. P. Kumar and D. Kumar, “Determination of Pharmaceuticals by UV-Visible Spectrophotometry,” Curr. Pharm. Anal. vol. 17, no. 9, pp. 1156–1170, 2021,
doi:10.2174/1573412917999200909144354.
[30] A. Felix Ojochegbe and I. Adams Udoji, “Dietary Iron Determination by UV-Visible Spectrophotometry in Beans, Egg, Fish, and Pork Sold in Makurdi, Nigeria,” IJSR, vol. 12, no. 10, pp. 1895–1899, 2023,
doi: 10.21275/sr231002144612.
Refbacks
- There are currently no refbacks.