NEW DEVELOPED AND VALIDATED SPECTROSCOPIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TERBINAFINE HYDROCHLORIDE AND FLUCONAZOLE
Objective: A new, simple, precise, accurate, and reproducible method or simultaneous equation method was developed and validated for the simultaneous estimation of terbinafine hydrochloride (TH) and fluconazole (FLZ) in pure form.
Methods: Simultaneous estimation of terbinafine hydrochloride and fluconazole was estimated by the ultraviolet (UV) spectrophotometry method. The method was based on the measurement of absorbance at two wavelengths 222 nm and 239 nm, of terbinafine hydrochloride and fluconazole in 0.1N HCl respectively.
Results: Calibration curves terbinafine hydrochloride and fluconazole were found to be linear in the concentration ranges of 0.5-3.0 μg/ml and 80-400 μg/ml, respectively, with their correlation coefficient values (R2) 0.999 and 0.998. LOD and LOQ of TH were found to be 0.067, 0.203 at 222 nm and 0.175, 0.531 at 239 nm, similarly for FLZ; 31.089, 94.210 at 222 nm and 94.380, 286.00 at 239 nm respectively. In the precision study, the % RSD value was found within limits (%). The percentage recovery at various concentration levels varied from 98.50 % to 103.96 % for TH and 97.27 % to 103.83 % for FLZ confirming that the expected method is accurate.
Conclusion: It could be concluded from the results obtained in the present study that this method for simultaneous estimation of TH and FLZ in pure is simple, precise, and economical. The proposed method can be applied successfully for the simultaneous estimation of TH and FLZ in the pure and pharmaceutical dosage form.
2. Sander CS, Hipler UC, Wollina U, Elsner P. Inhibitory effect of terbinafine on reactive oxygen species (ROS) generation by candida albicans. Mycoses 2002;45:152-5.
3. Balfour JA, Faulds D Terbinafine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial mycoses. Drugs 1992;43:259-84.
4. Krishnan Natesan S. Terbinafine: a pharmacological and clinical review. Expert Opin Pharmacother 2009;10:2723-33.
5. Hollier LM, Cox SM. Fluconazole (Diflucan). Infect Dis Obstet Gynecol 1995;3:222-5.
6. Mikamo H, Matsumizu M, Nakazuru Y, Okayama A, Nagashima M, et al. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan. J Infect Chemother 2015;21:520-6.
7. Zervos M, Meunier F. Fluconazole (Diflucan): a review. Int J Antimicrob Agents 1993;3:147-70.
8. Indian Pharmacopoeia. Vol. II. Government of India, Ministry of health and family welfare, The Indian Pharmacopoeia Commission, Ghaziabad Publication; 2010.
9. Lathiya Tushar, D Akhilesh, P Prabhakara, Kamath JV. Preformulation studies of controlled/sustained release formulations: an overview. Int Res J Pharm 2012;3:95-9.
10. Dewangan A, Tomar B, Mehta P, Singhai AK. Development and evaluation of terbinafine hydrochloride for tablet formulation. Int J Pharm Bio Sci 2013;1:36-52.
11. Charoo N, Cristofoletti R, Graham A, Lartey P, Abrahamsson B, Groot DW, et al. Biowaiver monograph for immediate-release solid oral dosage forms: fluconazole. J Pharm Sci 2014;103:3843-58.
12. Das S, Samanta A, Bose A. Design, development and evaluation of fluconazole topical gel. Asian J Pharm Clin Res 2015;8:132-5.
13. Attia KAM, El-Abasawi NM, El-Olemy A, Abdelazim AH. Application of different spectrophotometric methods for simultaneous determination of elbasvir and grazoprevir in pharmaceutical preparation. Spectrochim Acta A Mol Biomol Spectrosc 2018;189:154-60.
14. Abdel Halim LM, Abd El Rahman MK, Ramadan NK, El Sanabary HF, Salem MY. Comparative study between recent methods manipulating ratio spectra and classical methods based on two-wavelength selection for the determination of binary mixture of antazoline hydrochloride and tetryzoline hydrochloride. Spectrochim Acta A Mol Biomol Spectrosc 2016;159:98-105.
15. Rote AR, Kumbhoje PA, Bhambar RS. UV-visible spectrophotometric simultaneous estimation of paracetamol and nabumetone by AUC method in combined tablet dosage form. Pharm Methods 2012;3:40-3.
16. Ilango K, Kumar PS. Validated spectrophotometric methods for the simultaneous determination of telmisartan and atorvastatin in bulk and tablets. Pharm Methods 2012;3:112-6.
17. ICH Q2 (R1). Validation of analytical procedures: text and methodology. International Conference on Harmonization, IFPMA, Geneva; 2005.
18. Sawant RL, Hadawale SD, Dhikale GK, Bansode CA, Tajane PS. Spectrophotometric methods for simultaneous estimation of rabeprazole sodium and aceclofenac from the combined capsule dosage form. Pharm Methods 2011;2:193-7.
19. Shawna Rekshmy D’dharan, Ganapathy D. Medical management of denture stomatitis. Asian J Pharm Clin Res 2016;9:14-6.
20. Attimarad M, Narayanswamy VK, Aldhubaib BE, SreeHarsha N, Nair AB. Development of UV spectrophotometry methods for concurrent quantification of amlodipine and celecoxib by manipulation of ratio spectra in pure and pharmaceutical formulation. PloS One Vol 2019;14:e0222526.
21. Wadher SJ, Pathankar PR, Puranik M, Ganjiwale RO, Yeole PG. Simultaneous spectrophotometric estimation of paracetamol and metoclopramide hydrochloride in solid dosage form. Indian J Pharm Sci 2008;70:393-5.
22. Validation of analytical procedures: Text and methodology Q2 (R1). ICH Harmonised Tripartite Guideline; 2005. p. 1-13.
23. Venkatachalam T, Lalitha KG. Spectrophotometric methods for simultaneous estimation of melatonin and zolpidem from the combined tablet dosage form. Pharmacophore 2014;5:252-7.
24. Pandey G, Mishra B. A new analytical Q-absorbance ratio method-development and validation for simultaneous estimation method for lamivudine and isoniazid. Int Scholarly Res Not 2013;1:1-5.
25. Pandey S, Pandey P, Dubey S, Chaturvedi U, Rai K Awani. Facile derivative UV spectroscopy method: simultaneous estimation of tinidazole and fluconazole in combined tablet dosage form. Thai J Pharm Sci 2012;36:55-62.
This work is licensed under a Creative Commons Attribution 4.0 International License.