Volume : 13, Issue : 05, May – 2026
Title:
METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF TEZACAFTOR AND IVACAFTOR IN BULK DRUGS BY RP-HPLC
Authors :
A Sandya and R Rajitha
Abstract :
A rapid, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of tezacaftor and ivacaftor in bulk drugs. Chromatographic separation was performed on an Agilent Eclipse C18 ODS column (4.6 mm × 150 mm, 5 µm) using a mobile phase of triethylamine (TEA) and methanol (30:70 v/v) at a flow rate of 1.0 mL/min, with detection at 298 nm. The retention times of tezacaftor and ivacaftor were 2.46 and 4.38 min, respectively. The method showed linear responses over the concentration ranges of 10-50 µg/mL for tezacaftor and 15-75 µg/mL for ivacaftor. Method precision for the assay was below 2.0% RSD. Stress degradation studies were performed in accordance with the ICH guidelines.
Keywords: Tezacaftor, ivacaftor, RP-HPLC, validation, and estimation.
Cite This Article:
Please cite this article in press A sandhya et al., Method Development And Validation Of Simultaneous Estimation Of Tezacaftor And Ivacaftor In Bulk Drugs By Rp-Hplc ., Indo Am. J. P. Sci, 2026; 13(05).
REFERENCES:
1. Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pharmaceutical Analysis: Vol-II. 8th Ed. Pune: Nirali Prakashan; 2002: 48-57.
2. Shethi PD. HPLC- Quantitative analysis of pharmaceutical formulations. 1st Ed. New Delhi: CBS Publishers & Distributors; 2001: 8-10, 101-103.
3. Sharma BK. Instrumental Method of Chemical Analysis. 20th Ed. Meerut: Goel Publishing House; 2001: 54-83.
4. Skoog DA, West DM. Principles of Instrumental Analysis. 2nd Ed. Saunders Golden Sunburst Series. Philadelphia; 1980: 674-675, 690-696.
5. Drug Bank Open Data Drug and Drug Target Database. Version 4.1. http://www.drugbank.ca/drugs/DB01183.
6. Sonawane M. D., Gade S. T., and B. M. Narwate, Application of UV Spectrophotometer in Method Development and Validation for Simultaneous Estimation of Tezacafor and Ivacaftor In Pharmaceutical Dosage Form, World Journal of Pharmaceutical Research, Vol 7, Issue 14, 2018.
7. Narendra Singh, Parveen Bansal, Mukesh Maithani, Yashpal Chauhan, Development and Validation of a Novel Stability-Indicating RP-HPLC Method for Simultaneous Determination of Tezacaftor and Ivacaftor in Fixed Dose Combination, Journal of Chromatographic Science, Volume 58, Issue 4, April 2020, Pages 346–354.
8. Ramanjaneyulu K. V, Venkata Ramana K, M. Prasada Rao. Stability-Indicating LC Method Development and Validation for the Simultaneous Analysis of Cystic Fibrosis Drugs Ivacaftor and Tezacaftor in Pharmaceutical Formulations. Research J. Pharm. And Tech 2020; 13(5): 2076-2080.
9. Dharmamoorthy G, G. Sarath Kumar, Poornima B, P. Jayachandra Reddy, and K. Chandan Kumar. Stability Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ivacaftor and Tezacaftor in Bulk and Pharmaceutical Dosage Form, European Journal of Pharmaceutical and Medical Research, 2020,7(1), 342-346.
10. Pawanjeet J. Chhabda, M. Balaji, Srinivasarao V, Development and Validation Of A New And Stability Indicating RP-HPLC Method For The Determination Of Ivacaftor in the Presence Of Degradant Products, International Journal of Pharmacy and Pharmaceutical Sciences, Vol 5, Suppl 4, 2013.
11. N. Md. Akram and Dr. M. Umamahesh, A New Validated RP-HPLC Method For The Determination Of Lumacaftor And Ivacaftor In Its Bulk And Pharmaceutical Dosage Forms, Oriental Journal of Chemistry, 2017, Vol. 33, No. (3): Pg. 1492-1501.
12. B. Sravanthi, M. Divya, Analytical Method Development and Validation Of Ivacaftor And Lumacaftor by RP-HPLC Method, Indo American Journal Of Pharmaceutical Sciences, 2016, 3 (8), 900-904.
13. Gadeela Srimounika, Shyamala, J V C. Sharma, A. Swarupa. A New Stability Indicating Method for Simultaneous Estimation of Ivacaftor and Tezacaftor by RP-HPLC in Bulk and Its Dosage Form, International Journal of Research and Analytical Reviews (IJRAR), 2018 IJRAR December 2018, Volume 5, Issue 4, Pages: 774-785.
14. Heinisch S, Rocca JL. Effect of mobile-phase composition, pH, and buffer type on the retention of ionizable compounds in reversed-phase liquid chromatography: application to method development. J. Chromatogr. A. 2004; 183–193.
15. Gritti F, Guiochon G. Role of the buffer in retention and adsorption mechanism of ionic species in reversed phase liquid chromatography. J. Chromatogr A. 2004; 1038(1-2):53–66.
16. Bosch E, Espinosa S, Roses M. Retention of ionizable compounds on high-performance liquid chromatography: III. Variation of pKa values of acids and pH values of buffers in acetonitrile–water mobile phases. J. Chromatogr. A. 1998; 824(2):137–146.
17. Kupiec T. Quality control analytical methods: high-performance liquid chromatography. Int. J. Pharma. Compound. 2004; 8(3): 223-227.
18. Wuelfing WP, Kosuda K, Templeton AC, et al. Polysorbate 80 UV/ vis spectral and chromatographic characteristics – defining boundary conditions for use of the surfactant in dissolution analysis. J Pharm Biomed Anal, 2006; 41: 774-82.
19. Sweetman SC. 2009. Martindale’s Complete Drug Reference. London: Pharmaceutical Press.
20. Valko K, Snyder LR, Glajch J. Retention in Reversed-Phase Liquid Chromatography as a function of mobile phase composition. J. Chromatogr. A. 1993; 656(2): 501-520.
21. S. Lakshmi Maneka, R. T. Saravanakumar, C.N. Anjana. Development and validation of a stability-indicating RP-UPLC method for the simultaneous estimation of Tezacaftor and Ivacaftor in formulations. International Journal of Pharmacy and Pharmaceutical Sciences. Vol 12, Issue 9, 2020.
22. Ayyappa, M. Rama; Babu, G. Raveendra; Sushama, C.; Sowjanya, M.; Murthy, G. Lakshmana. A Novel Stability-Indicating RP-HPLC method for the simultaneous analysis of Ivacaftor and Tezacaftor in Pure and Its Pharmaceutical Formulations. International Journal of Pharmaceutical, Chemical & Biological Sciences. Oct-Dec 2019, Vol. 9 Issue 4, p172- 179.