Y. Padmavathi, N. Raghavendra Babu, K. Rohini, Ashraf A. Khanam, R. Padmavathi
Y. Padmavathi, N. Raghavendra Babu*, K. Rohini, Ashraf A. Khanam, R. Padmavathi
Department of Pharmaceutical Analysis, G.Pulla Reddy College of Pharmacy Mehdipatnam, Hyderabad -500028, TS, India.
Volume - 15,
Issue - 5,
Year - 2022
A new analytical method has been developed for the simultaneous estimation of Montelukast sodium and Fexofenadine hydrochloride in pharmaceutical dosage forms using chemometrically assisted Fourier Transform Infrared (FTIR) Spectroscopy. This method involves preparation of solid pellets of Montelukast sodium and Fexofenadine hydrochloride using Potassium bromide (KBr) with the aid of geometric mixing. The spectra were measured by direct measurement technique using reduced path length in absorbance mode and the equipment was configured to collect spectra at 8cm-1 resolution. The spectra were collected between the ranges of 4000cm-1 to 450cm-1. Infrared spectra of the two drugs showed different functional group peaks with base line correction; from which intense, clear and proportionate peaks at 1704cm-1 and 3421cm-1 corresponding to C=O stretching and O- H group were selected for Montelukast and Fexofenadine respectively for quantitative estimation using chemometrics. Beer-Lambert’s law was obeyed over the concentration range of 5-25 µg/mg for Montelukast and Fexofenadine. The developed method was validated according to International Conference on Harmonisation (ICH) guidelines. The validation parameters - precision, accuracy, limit of quantitation, limit of detection were determined and found to be within the limits. This method was successfully applied for analysis of marketed formulations of Montelukast sodium and Fexofenadine hydrochloride.
Cite this article:
Y. Padmavathi, N. Raghavendra Babu, K. Rohini, Ashraf A. Khanam, R. Padmavathi. Development and Validation of Chemometric Assisted Fourier Transform Infrared Spectroscopic Method for Simultaneous Determination of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2022; 15(5):2261-7. doi: 10.52711/0974-360X.2022.00376
Y. Padmavathi, N. Raghavendra Babu, K. Rohini, Ashraf A. Khanam, R. Padmavathi. Development and Validation of Chemometric Assisted Fourier Transform Infrared Spectroscopic Method for Simultaneous Determination of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2022; 15(5):2261-7. doi: 10.52711/0974-360X.2022.00376 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-5-58
1. Pubchem of montelukast sodium [Online] https://pubchem.ncbi.nlm.nih.gov/compound/Montelukast-sodium
2. Pubchem of fexofenadine hydrochloride[Online] https://pubchem.ncbi.nlm.nih.gov/compound/Fexofenadine-hydrochloride
3. Parfit K Martindale, The Complete Drug Reference(34 ed.), The Pharmaceutical Press, London, UK (2005)435, 788.
4. HP Rang, MM Dale, JM Ritter, RJ Flower, G Henderson, Rang & Dale’s Pharmacology, 7th Edition, Spain, Elsevier Churchil Livingstone, 2012
5. Douglas A Skoog, F James Holler, Stanley R Crouch, Principles of Instrumental Analysis, 6th Edition, Delhi, Cengage Learning, 2007.
6. Pavia, Lampman, Kriz, Vyvyan, Introduction To Spectroscopy, 4th Edition, California, Brooks Cole Publishers; 2008.
7. Gurdeep R Chatwal, Sham K Anand, Instrumental Methods of Chemical Analysis, 5th Edition, Mumbai, Himalaya Publishers, 2005.
8. Barbara Stuart, Bill George, Peter McIntyre, Modern Infrared Spectroscopy,2nd Edition, New Delhi, Wiley India Publishers, 2008.
9. Goran S Nikolic, Fourier Transforms New Analytical Approaches and FTIR Strategies, USA, INTECH Publishers, 2011.
10. Michael Bradley, Advantages of a Fourier Transform Spectrometer- Technical Note: 50674, Madison, WI, USA, Thermo Fisher Scientific, 2008.
11. G Sowjanya, K Trideva Sastri, UV Spectrophotometric Method Development and Validation for Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium in Tablets, World Journal of Pharmacy and Pharmaceutical Sciences, 2017,6(10):780-789.
12. Dipti G. Phadtare, Amol R. Pawar, Rajashri R. Kulkarni, Govind K. Patil. Validated UV Spectroscopic Method for Estimation of Montelukast sodium from Bulk and Tablet Formulations. Asian J. Research Chem. 2016; 9(7): 335-338.
13. HakanAktaş, FilizKitis, Spectrophotometric Simultaneous Determination of Caffeine and Paracetamol in Commercial Pharmaceutical by Principal Component Regression, Partial Least Squares and Artificial Neural Networks Chemometric Methods, CroaticaChemicaActa, 2014, 87(1):69-74.
14. Khadiga M Kelani , Abdallah A Shalaby , Magda Y Elmaamly , Michael K Halim, Development of Spectrophotometric and Chemometric Methods for Simultaneous Determination of Two Anti-Hypertensive Drugs in their Combined Dosage Form, PharmaceuticaAnalyticaActa, 2014, 6(1).
15. Rajeev Kumar P, Rekha Rajeev Kumar. Q analysis of Montelukast sodium and Fexofenadine hydrochloride in Tablet Formulation by Derivative Spectrophotometry. Asian J. Research Chem. 2017; 10(2):174-178.
16. Anuruddha R Chabukswar, Vishnu P. Choudhari , Shailesh N. Sharma, Nilesh A. Bari, Dhaval Ghuge. Ratio derivative spectrophotometry method for simultaneous estimation of Montelukast and Fexofenadine HCl in their combined dosage form. Asian J. Research Chem. 5(5): May 2012; Page 637-641.
17. C. A. Gulhane, S. S. Khadabadi, S. C. Atram. Analytical Method Development and Validation for Simultaneous Estimation of some drugs in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2019; 9(3):107-112.
18. Anuj Narang, Usha Y. Nayak, Bisakha Roy, Reema Narayan. Formulation Design of Bilayer Dual-Release Tablet composition of Fexofenadine HCl and Montelukast Sodium. Research J. Pharm. and Tech 2016; 9(9):1410-1416.
19. Narang A, Nayak UY, Roy B, Narayan R. Formulation design of bilayer dual-release tablet composition of fexofenadine HCl and montelukast sodium. Research Journal of Pharmacy and Technology. 2016;9(9):1410-6.
20. Polawar PV, Shivhare UD, Bhusari KP, Mathur VB. Development and validation of spectrophotometric method of analysis for fexofenadine HCl. Research Journal of Pharmacy and Technology. 2008;1(4):539-40.
21. Ramesh J, Jayalakshmi B, Vijayamirtharaj R, Prakasam KC. Simultaneous Estimation of Montelukast Sodium and Levocetrizine Hydrochloride by UV-Visible Spectrometry. Asian Journal of Research in Chemistry. 2011;4(1):104-9.
22. Hitesh Vekaria, KSMuralikrishna and MandipSorathiya, Development and validation of HPTLC method for simultaneous estimation of montelukast sodium and fexofenadine hydrochloride in combined dosage form, Der Pharmacia Lettre,2012, 4 (3):755-762.
23. Tamilselvi N, Sruthi K, Arivukkarasu R, Vanathi P, Deepthi Visakh. Development of Validated HPTLC Method for Simultaneous Estimation of Fexofenadine Hydrochloride and Montelukast Sodium in Tablet Dosage form. Research J. Pharm. and Tech. 2016; 9(4): 469-473.
24. Rituraj Singh Chundawat, Y.S. Sarangdevot, R.P.S. Rathore, Dharmendra Singh Sisodiya, Udaibhan Singh Rathore. Method Development and Validation for Simultaneous Estimation of Montelukast and Fexofenadine in Pharmaceutical Dosage Form by HPLC Method. Research J. Pharm. and Tech. 6(10): October 2013; Page 1102-1106.
25. K Prashanth Kumar, M AkifulHaque, T Pradeep Kumar, G Nivedita,S Hasan amrohi, VVLN Prasad, et al., Simultaneous Determination of Montelukast Sodium and Fexofenadine Hydrochloride in Combined Dosage Form by Using RP-HPLC Method, World Journal of Chemistry, 2012, 7(2):42-46.
26. Nishant Sarode, G. S. Chhabra, Shailesh Luhar, Anil Jadhav. Development and Validation of RP-HPLC Method for the Estimation of Montelukast Sodium in Bulk and In Tablet Dosage Form. Research J. Science and Tech. 2011; 3(5): 257-260.
27. MounikaGodavarthi, K Sujana, A Pramila Rani,Method development and validation for the simultaneous determination of fexofenadine hydrochloride and montelukast sodium using rp-hplc, IOSR Journal of Pharmacy,2012,2(5):41-48.
28. Mohamed Mustafa, S. Amuthalakshmi, C.N. Nalini. Simultaneous UPLC Estimation of Fexofenadine HCl and Montelukast Sodium Tablets. Research J. Pharm. and Tech. 2017; 10(2): 557-561.
29. Anirudha R Chabukswar, Vishnu PChoudhari, Swati C Jagdale, Shialesh N Sharma, Nilesh A Bari, Bharat D Pagare,et al.,Simultaneous Estimation of Montelukast Sodium and FexofenadineHCL in Pharmaceutical Formulation by RP-LC-PDA, International Journal of Pharma Sciences and Research (IJPSR), 2012, 3(1):241-248.
30. Marwa AA Ragab, Rasha M Youssef,Simultaneous Determination of Montelukast and Fexofenadine Using Fourier Transform Convolution Emission Data Under Non- Parametric Linear Regression Method, Journal of Fluorescence (J Fluoresc), 2013, 23(6):1341.
31. Advaita B. Patel. Analytical Method Validation: Collation between International Guidelines. Asian J. Research Chem. 2017; 10(6):857-866.
32. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.. ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2 (R1). November 2005.