Validation of Finasteride Tablets USP by HPLC Isocratic with UV Detector

Dillip Kumar Mohapatra; Rajesh K Nayak; Deepika Rani Panigrahi; Surya Narayan Das

doi:10.32628/IJSRST25121163

Authors

Dillip Kumar Mohapatra Gayatri College of Pharmacy, Sambalpur, Odisha, India Author
Rajesh K Nayak Gayatri College of Pharmacy, Sambalpur, Odisha, India Author
Deepika Rani Panigrahi Maa Samalai Pharmacy College, Sambalpur, Odisha, India Author
Surya Narayan Das Gayatri College of Pharmacy, Sambalpur, Odisha, India Author

DOI:

https://doi.org/10.32628/IJSRST25121163

Keywords:

Fenasteride, Kromasil ODS C18, ICH guidelines, Placebo, t-test, F-test

Abstract

The aims of this work were to validate the analytical method, and evaluate the fenasteride in bulk drug commercial products by HPLC. Fenasteride was eluted from a Kromasil ODS C18, 150 mm x 4.6 mm, 5 at laboratory temperature (30 ± 2º C) with a mobile phase consisting of Acetonitrile and 2.5M Ortho phosphoric acid (50:50 %v/v) at a flow rate of 1.0 mL/min with UV detection at 240 nm. The retention time was about 3.45 minutes and each analysis took not more than 8 minutes. The result obtained for each parameter including Specificity, System Precision, Method Precision (Repeatability), Intermediate precision (Ruggedness), Solution stability, Filter Paper Interference and System suitability lies well within the acceptance criteria. Blank preparation and Placebo preparation did not show any interference at the retention time of Finasteride and peak purity of main peak in Standard preparation, Test preparation and Test spiked preparation is 1000. Ruggedness of the method was evaluated under intermediate precision and results were found within acceptable limits. The presented methods were validated (regarding ICH guidelines) and statistically compared by applying the t-test and F-test with the reported method. The proposed validated methods were found to be sensitive, selective, and can be successfully used for quality control test. Since the results are within acceptance criteria for all parameters, therefore the method is considered as validated and suitable for intended use.

Downloads

Download data is not yet available.

References

J. K. Parsons, Curr. Bladder Dysfunct. Rep., 2010, 5, 212–218. DOI: https://doi.org/10.1007/s11884-010-0067-2

D. E. Irwin, Z. S. Kopp, B. Agatep, I. Milsom and P. Abrams, BJU Int., 2011, 108, 1132–1138. DOI: https://doi.org/10.1111/j.1464-410X.2010.09993.x

Cha, E. K.; Shariat, S. F. The Use of 5-Reductase Inhibitors for the Prevention and Treatment of Prostat Cancer. Eur. Urol. 2011, 59 (4), 515–517. DOI: https://doi.org/10.1016/j.eururo.2011.01.028

Lucas, J. K. Finasteride in the Treatment of Hirsutism. J. Women’s Health 1995, 4 (6), 655–661. DOI: https://doi.org/10.1089/jwh.1995.4.655

Mella, J. M.; Perret, M. C.; Manzotti, M.; Catalano, H. N.; Guyatt, G. Efficacy and Safety of Finasteride Therapy for Androgenetic Alopecia. Arch. Dermatol. 2010, 146 (10), 1141–1150. DOI: https://doi.org/10.1001/archdermatol.2010.256

Tully, A. S.; Schwartzenberger, J.; Studdiford, J. Androgenic Alopecia. J. Mens Health 2010, 7 (3), 270–277. DOI: https://doi.org/10.1016/j.jomh.2010.08.006

Yamazaki, M.; Miyakura, T.; Uchiyama, M.; Hobo, A.; Irisawa, R.; Tsuboi, R. Oral finasteride improved the quality of life of androgenetic alopecia. J. Dermatol. 2011, 38 (8), 773–777. DOI: https://doi.org/10.1111/j.1346-8138.2010.01126.x

Shraddha T. Nemane, 1Sachin B. Gholve, Development and validation of a RP-HPLC method for determination of finasteride in pharmaceutical dosage forms.WJPR, Volume 9, Issue 2, 883-895

Hardman, J. G.; Limbard, L. E.; Gilman, A. G. Goodman Gilman’s: The pharmacological Basis of Therapeutics 9th ed McGraw-Hill, NewYork, 2001.

Martindale, The Extrapharmacopoeia, 30th Edn; The pharmaceutical Press London. 1994 p 691.

The United States of Pharmacopeia. United States Pharamcopoeial Convention Inc., Rockville. 2005, 29, 907.

Xiaohong, C.; Erin, R. G.; Douglas, K. P.; William, D. F.; Development and validation of an LC-MS assay for finasteride and its application to prostate cancer prevention trial sample analysis J. Chromatogr. Sci. 2008, 46, 356–361. DOI: https://doi.org/10.1093/chromsci/46.4.356

Ptacek, P.; Macek, J.; Klima, J.; Determination of finasteride in human plasma by liquid- liquid extraction and high performance liquid chromatography J. Chromatogr. 2000, 738, 305–310. DOI: https://doi.org/10.1016/S0378-4347(99)00543-5

Nasare, M. K.; Satish, J.; Amrohi, S. H.; Harshini, S.; Kumar, M.; Simultaneous determination of finasteride and tamsulosin in combined dosage form by using RP-HPLC method J. Liq. Chromatogr. Rel. Tech. 2014, 37, 1176–1186. DOI: https://doi.org/10.1080/10826076.2013.778637

Sindhura, M.; Raghavi, K.; Prashanthi, R.; Nalluri, B. N.; Simultaneous estimation of finasteride and tamsulosin hydrochloride in combined dosage form by using RP-HPLC-PDA method J. Appl. Pharm. Sci. 2012, 2, 203–209.

ICH Q2A, Harmonised tripartite Guide line, Text on validation of analytical procedures: Methodology, International Conference on Harmonization, Geneva, March, 1994.

ICH Q2B Harmonized tripartite Guide line, Text on validation of analytical procedures: Methodology, International Conference on Harmonization, Geneva, March, 1994.

ICH guidance on Analytical method validation, International convention on quality for Pharmaceutical Industry, Toronto, Canada, September 2002.