SIMULTANEOUS ANALYSIS OF ISONIAZID AND PYRIDOXINE HYDROCHLORIDE IN TABLETDOSAGE FORM USING PARTIAL LEAST SQUARES BASED ON INFRAREDSPECTRA PROFILE
DOI:
https://doi.org/10.22159/ijap.2025v17i2.52853Keywords:
Isoniazid, Pyridoxine hydrochloride, Chemometrics, Partial least squareAbstract
Objective: The purpose of this research was to simultaneously analyse a mixture of Isoniazid (INH) and Pyridoxine Hydrochloride (PDX) in tablet dosage form using Partial Least Square (PLS) based on infrared spectra profile.
Methods: The calibration models were measured at five concentrations levels (w/w) of INH and PDX within the wavenumber ranges of 779.24-713.66 cm-1 for INH and 829.39-763.81 cm-1for PDX. Model performance was evaluated through internal validation using leave-one-out-cross validation (LOO-CV), with accuracy and precision assessed by the coefficient of determination (R2), Prediction Error Sum of Squares (PRESS), and Root Mean Square Error of Cross Validation (RMSECV). Divisor approach was applied to separate the spectrum of the individual components within the mixture.
Results: The PLS models for INH and PDX levels showed excellent validation results, with R2 values of 0.9996 and 0.9969, PRESS values of 0.8106 and 0.3129, and RMSCEV values of 0.3675 and 0.2283, respectively. The INH level on INHA® 400 and Pehadoxin Forte® tablets were 102.90% and 105.45% of the labelled amount, while the PDX level was 98.93% and 101.57% of the labelled amount, respectively.
Conclusion: The PLS model based on infrared spectra profiles demonstrated high accuracy, precision, and effectiveness, offering a non-destructive method for simultaneous analysis of INH and PDX in tablet dosage form. This method is applicable to pharmaceutical quality monitoring.
Downloads
References
Hladová M, Martinka J, Rantuch P, Nečas A. Review of Spectrophotometric Methods for Determination of Formaldehyde. Research Papers Faculty of Materials Science and Technology Slovak University of Technology. 2019 Jun 1;27(44):105–20. Available from: http://dx.doi.org/10.2478/rput-2019-0012
Lotfy HM, Saleh SS. Recent Development in Ultraviolet Spectrophotometry Through The Last Decade (2006–2016): A Review. International Journal of Pharmacy and Pharmaceutical Sciences. 2016 Aug 12;8(10):40. Available from: http://dx.doi.org/10.22159/ijpps.2016v8i10.13537
Sayed Saad A, Hamdy A, Merey H, Ibrahim H. Novel spectrophotometric method for the analysis of ternary mixtures. ERU Research Journal. 2022 Oct 1;1(1):75–92. Available from: http://dx.doi.org/10.21608/erurj.2022.267925
Aastha Dutta. Chapter 4. Fourier Transform Infrared Spectroscopy. Editor(s): Sabu Thomas, Raju Thomas, Ajesh K. Zachariah, Raghvendra Kumar Mishra. In Micro and Nano Technologies, Spectroscopic Methods for Nanomaterials Characterization. Elsevier. 2017. Pages 73-93. https://doi.org/10.1016/B978-0-323-46140-5.00004-2.
Mallah MA, Sherazi STH, Bhanger MI, Mahesar SA, Bajeer MA. A rapid Fourier-transform infrared (FTIR) spectroscopic method for direct quantification of paracetamol content in solid pharmaceutical formulations. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2015 Apr;141:64–70. Available from: http://dx.doi.org/10.1016/j.saa.2015.01.036.
Windarsih A, Riswanto FDO, Bakar NKA, Yuliana ND, Dachriyanus, Rohman A. Detection of Pork in Beef Meatballs Using LC-HRMS Based Untargeted Metabolomics and Chemometrics for Halal Authentication. Molecules. 2022 Nov 29;27(23):8325. Available from: http://dx.doi.org/10.3390/molecules27238325.
Patel R, Mashru R. Development and Validation of Chemometric Assisted Methods and Stability Indicating RP-HPLC Method for Simultaneous Estimation of Rasagiline Mesylate and Pramipexole in Synthetic Mixture. Acta Scientific Pharmaceutical Sciences. 2019 Jul 31;3(8):154–68. Available from: http://dx.doi.org/10.31080/asps.2019.03.0359
Rohman A, Ramadhani D, Nugroho A. Analysis of Curcumin in Curcuma longa and Curcuma xanthorriza Using FTIR Spectroscopy and Chemometrics. Research Journal of Medicinal Plant. 2015 Apr 1;9(4):179–86. Available from: http://dx.doi.org/10.3923/rjmp.2015.179.186
Munir Ma, Inayatullah A, Ibrahim S, Rimba Putri Ir, Emelda E, Fatmawati A, Et Al. A Modest Uv Spectrophotometric Assisted By Chemometric Approach For Verification Of Acetaminophen Level In Various Manufactured Tablets And Syrups In Indonesian Pharmacies. International Journal of Applied Pharmaceutics. 2023 Jan 7;195–205. Available from: http://dx.doi.org/10.22159/ijap.2023v15i1.46290
Alaoui Mansouri, M., Kharbach, M., El Maouardi, M., Barra, I., &Bouklouze, A. (2023). Quantification of ciprofloxacin in pharmaceutical products from various brands using FT-NIR: A comparative investigation of PLS and MCR-ALS. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 303, [123268]. https://doi.org/10.1016/j.saa.2023.123268
Pinto L, Stechi F, Breitkreitz MC. A simplified and versatile multivariate calibration procedure for multiproduct quantification of pharmaceutical drugs in the presence of interferences using first order data and chemometrics. Microchemical Journal. 2019 May;146:202–9. Available from: http://dx.doi.org/10.1016/j.microc.2019.01.014
Adriyani A, Rifai Y, Yulianty R. Determination of Pseudoephedrine HCl, Guaifenesin, and Triprolidine HCl Simultaneously in Syrup Formulations Using HPLC Method. MajalahFarmasi dan Farmakologi. 2018 Dec 19;22(1):5–7. Available from: http://dx.doi.org/10.20956/mff.v22i1.5688
Nasution LR, Bachri M, Putra EDL. Simultaneous Estimation pf Isoniazid and Pyridoxine Hydrochloride in Tablet Dosage Form by Spectrophotometry Ultraviolet with Area Under Curve Method. Asian Journal of Pharmaceutical and Clinical Research. 2018 May 1;11(5):124. Available from: http://dx.doi.org/10.22159/ajpcr.2018.v11i5.24314
Benjamin T, Ramachandran D. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Isoniazid & Pyridoxine in Bulk and It Pharmaceutical Formulations. American Journal of PharmTech Research. 2019 Feb 8;9(1):215–25. Available from: http://dx.doi.org/10.46624/ajptr.2019.v9.i1.015
AKTAŞ AH, MuhıAllawAhbabi A. Simultaneous Determination Of Valsartan And Hydrochlorothiazide By First-Order Derivative- Zero Crossing Uv-Visible Spectrophotometric Method. Universal Journal of Pharmaceutical Research. 2022 Sep 15; Available from: http://dx.doi.org/10.22270/ujpr.v7i4.808
TariganRE, Yustifin, S. Determination of Isoniazid and Pyridoxine Hydrochloride Levels in Tablets with Ultraviolet Spectrophotometry by Successive Ratio Derivative. AMSPH 3 (1) (2022) Pages: 95-101. http://pcijournal.org/index.php/iamsph/index
Lotfy HM, Saleh SS. Investigating Advanced Approaches Based on Iso-Absorptivity Coefficient in Unresolved Spectra Signals of Binary Mixtures. Journal of Analytical Methods in Chemistry. 2019 Feb 3;2019:1–10. Available from: http://dx.doi.org/10.1155/2019/7924821
Moffat, A.C., Osselton, M.D., Widdop, B. Clarke’s Analysis of Drugs and Poisons. 4th Edition. London: Pharmaceutical Press. 2011. Pages. 1530, 1988.
Shoukat U, Baumeister E, Knuutila HK. ATR-FTIR Model Development and Verification for Qualitative and Quantitative Analysis in MDEA–H2O–MEG/TEG–CO2 Blends. Energies. 2019 Aug 26;12(17):3285. Available from: http://dx.doi.org/10.3390/en12173285
Lotfy HM, Morgan EM, Fayez YM, Abdelkawy M. Different aspects in manipulating overlapped spectra used for the analysis of trimebutine maleate and structure elucidation of its degradation products. Future Journal of Pharmaceutical Sciences . 2019 Nov 12;5(1). Available from: http://dx.doi.org/10.1186/s43094-019-0004-y
Paris Junior J, Cavicchioli M, Machado R, Pavan F, Nakahata DH, Corbi P, et al. Synthesis, Characterization, Dft Modeling And In Vitro Antimycobacterial Activity Assays Of A Silver(I)-Isoniazid Complex. Química Nova. 2020; Available from: http://dx.doi.org/10.21577/0100-4042.20170681
Hidayati N, Fianti A, Arnela M. Study of Boron Complexation with Pyridoxine: Effect of Interaction Time, Temperature, and Amount of Pyridoxine. Indonesian Journal of Fundamental and Applied Chemistry. 2023 Jun 26;8(2):76–81. Available from: http://dx.doi.org/10.24845/ijfac.v8.i2.76
Alauhdin M, Eden WT, Alighiri D. Application of Infrared Spectroscopy for the Analysis of Plants and Herbal Medicines. isk. 2021 May 5 [cited 2024 Oct. 3];4. Available from: https://bookchapter.unnes.ac.id/index.php/ISK/article/view/15
En, Zhou, Ye., Run, Zhou, Ye., En, Hui, Ye., Joseph, Ye., J., Ye. Supplemental Table 1 for Relationship between the concentration of green ink in distilled water and integrated photon absorbance measured using a 3D-printed spectrometer. (2023). doi: 10.6084/m9.figshare.21987344
Andrews SS, Boxer SG. Analysis of Noise for Rapid-Scan and Step-Scan Methods of FT-IR Difference Spectroscopy. Applied Spectroscopy. 2001 Sep;55(9):1161–5. Available from: http://dx.doi.org/10.1366/0003702011953414
Sandt C, Waeytens J, Deniset-Besseau A, Nielsen-Leroux C, Réjasse A. Use and misuse of FTIR spectroscopy for studying the bio-oxidation of plastics. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2021 Sep;258:119841. Available from: http://dx.doi.org/10.1016/j.saa.2021.119841
Richard, G., Brereton. Multivariate Calibration. (2024).305-319. doi: 10.1002/9781119639398.ch8
Mallah MA, Sherazi STH, Mahesar SA, Khaskheli AR. Simultaneous Quantification of Ibuprofen and Paracetamol in Tablet Formulations Using Transmission Fourier Transform Infrared Spectroscopy. American Journal of Analytical Chemistry. 2012;03(08):503–11. Available from: http://dx.doi.org/10.4236/ajac.2012.38067
Przybył K, Koszela K, Adamski F, Samborska K, Walkowiak K, Polarczyk M. Deep and Machine Learning Using SEM, FTIR, and Texture Analysis to Detect Polysaccharide in Raspberry Powders. Sensors. 2021 Aug 30;21(17):5823. Available from: http://dx.doi.org/10.3390/s21175823
Rohman, A.Vibrational Spectroscopy: Theory and Its Applications for Pharmaceutical Analysis. Yogyakarta: Gadjah Mada University Press. 2014. Pages 18-21, 28-29, 34-52, 79, 82-83.
Raturandang R, Wenas DR, Mongan S, Bujung C. FTIR Spectroscopy Analysis for the Chemical and Physical Characterization of Hot Spring Fluids in the Pine Forest Tourism Area of Tomohon, North Sulawesi. JurnalFisTa :Fisika dan Terapannya. 2022 May 3;3(1):28–33. Available from: http://dx.doi.org/10.53682/fista.v3i1.167
Taghizade M, Ebrahimi M, Fooladi E, Yoosefian M. Simultaneous spectrophotometric determination of the residual of ciprofloxacin, famotidine, and tramadol using magnetic solid phase extraction coupled with multivariate calibration methods. Microchemical Journal. 2021 Jan;160:105627. Available from: http://dx.doi.org/10.1016/j.microc.2020.105627
Nengsih TA, Bertrand F, Maumy-Bertrand M, Meyer N. Determining the number of components in PLS regression on incomplete data set. Statistical Applications in Genetics and Molecular Biology. 2019 Nov 6;18(6). Available from: http://dx.doi.org/10.1515/sagmb-2018-0059
Deng BC, Yun YH, Liang YZ, Cao DS, Xu QS, Yi LZ, et al. A new strategy to prevent over-fitting in partial least squares models based on model population analysis. Analytica ChimicaActa. 2015 Jun;880:32–41. Available from: http://dx.doi.org/10.1016/j.aca.2015.04.045.
Published
How to Cite
Issue
Section
Copyright (c) 2024 LISDA RIMAYANI NASUTION, SEREN ERNEST FLAVIA, YADE METRIPERMATA, MUCHLISYAM BACHRI, HAFID SYAHPUTRA, CHEMAYANTI SURBAKTI
This work is licensed under a Creative Commons Attribution 4.0 International License.
