Stability Indicating Method Development and Validation of Finasteride by High-Performance Thin-Layer Chromatography Studies

Sanjay Sawant; Minal Ghante

doi:10.14233/ajchem.2017.20661

Issue

Vol. 29 No. 10 (2017): Vol 29 Issue 10

Issue Published : August 31, 2017

This work is licensed under a Creative Commons Attribution 4.0 International License.

Stability Indicating Method Development and Validation of Finasteride by High-Performance Thin-Layer Chromatography Studies

https://doi.org/10.14233/ajchem.2017.20661

Sanjay Sawant

Sinhgad Technical Education Society's Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk.), Pune-411 048, India

Minal Ghante

Sinhgad Technical Education Society's Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk.), Pune-411 048, India

Corresponding Author(s) : Minal Ghante

mrghante@gmail.com

Asian Journal of Chemistry, Vol. 29 No. 10 (2017): Vol 29 Issue 10
Article Published : August 31, 2017

Abstract

The present research work determines the stability of finasteride by forced degradation studies. Finasteride was treated with hydrolytic stressors such as acid, alkali and neutral stress, further finasteride was also treated with oxidative, photolytic and thermal stress conditions. Method development, validation and separation of the degradation products for the drug were carried out by using high-performance thin-layer chromatographic system (HPTLC). The drug was found to degrade under basic and oxidative stress conditions. The mobile phase composition for HPTLC analysis consisted of chloroform-methanol (8:2 % v/v). The UV spectrophotometric spectra of finasteride showed l_max at 210 nm; hence this wavelength was chosen for densitometric analysis. The R_F value for finasteride was found to be 0.57 with a compact spot. The method was validated as per ICH guidelines Q2(R1) and good linear relationship was observed in the concentration range of 200-1400 ng band^–1. Percent recovery for the drug was within limit and was found to be in the range of 98.52–99.66 %. For precision studies the % relative standard deviation (% RSD) was < 1.5 %. The developed HPTLC method has been successfully applied for the analysis of finasteride in tablet dosage form.

Keywords

Finasteride Stability indicating method HPTLC

Sawant, S., & Ghante, M. (2017). Stability Indicating Method Development and Validation of Finasteride by High-Performance Thin-Layer Chromatography Studies. Asian Journal of Chemistry, 29(10), 2159–2162. https://doi.org/10.14233/ajchem.2017.20661

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References

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References

C.J. Girman, Br. J. Urol., 82(S1), 34 (1998); https://doi.org/10.1046/j.1464-410X.1998.0820s1034.x.

G.H. Rasmusson, G.F. Reynolds, T. Utne, R.B. Jobson, R.L. Primka, C. Berman and J.R. Brooks, J. Med. Chem., 27, 1690 (1984); https://doi.org/10.1021/jm00378a028.

S.C. Sweetman, In: Martindale, The Complete Drug Reference, The Pharmaceutical Press, London, edn 34, p. 1549 (2005).

J. Macek, J. Chromatogr. B Biomed. Sci. Appl., 764, 207 (2001); https://doi.org/10.1016/S0378-4347(01)00317-6.

Indian Pharmacopeia, Government of India, Ministry of Health and Family Welfare, Indian Pharmacopoeia Commission, vol. II, pp. 649-651 (2010).

British Pharmacopoeia, Her Majesty’s Stationery Office, London, vol. 1, p. 916 (2010).

United State Pharmacopeia 32: National Formulary 27; The United State Pharmacopeial Convention, Rockville, p. 1449 (2009).

S. Agarwal, K.V. Gowda, A.K. Sarkar, D. Ghosh, U. Bhaumik, T.K. Chattaraj and T.K. Pal, Chromatographia, 67, 893 (2008); https://doi.org/10.1365/s10337-008-0613-7.

S.T. Ulu, Spectrochim. Acta A, 67, 778 (2007); https://doi.org/10.1016/j.saa.2006.08.032.

M. Thimmaraju, V. Rao, S. Gurrala and J.G. Reddy, Int. J. Pharma Bio Sci., 1, 39 (2011).

S. Saglik and S. Tatar Ulu, Anal. Biochem., 352, 260 (2006); https://doi.org/10.1016/j.ab.2006.01.048.

F.Q. Guo, L.F. Huang, K.P. Wong, Y.H. Dai, Y.W. Li, Y.Z. Liang, K.L. Huang, K.J. Zhong and M.J. Wu, J. Pharm. Biomed. Anal., 43, 1507 (2007); https://doi.org/10.1016/j.jpba.2006.10.024.

X. Chen, E.R. Gardner, D.K. Price and W.D. Figg, J. Chromatogr. Sci., 46, 356 (2008); https://doi.org/10.1093/chromsci/46.4.356.

K. Basavaiah and B.C. Somashekar, E-J. Chem., 4, 109 (2007); https://doi.org/10.1155/2007/519262.

A.I. Segall, M.F. Vitale, V.L. Perez, M.L. Palacios and M.T. Pizzorno, J. Liq. Chromatogr. Rel. Technol., 25, 3167 (2002); https://doi.org/10.1081/JLC-120016216.

G. Srinivas, K.K. Kumar, Y.R. Koti Reddy, K. Mukkanti, G.V. Kanumula and P. Madhavan, J. Chem. Pharm. Res., 3, 987 (2011).

A.A. Syed and M.K. Amshumali, J. Pharm. Biomed. Anal., 25, 1015 (2001); https://doi.org/10.1016/S0731-7085(01)00385-5.

Y.K. Reddy, G.V.S. Reddy, K.N.J. Veera and K.K. Hotha, Am. J. Anal. Chem., 3, 737 (2012); https://doi.org/10.4236/ajac.2012.311098.

M. Sindhura, K. Raghavi, R. Prashanthi and B.N. Nalluri, J. Appl. Pharm. Sci., 2, 203 (2012); https://doi.org/10.7324/JAPS.2012.2626.

T.S. Belal, M.S. Mahrous, M.M. Abdel-Khalek, H.G. Daabees and M.M. Khamis, Anal. Chem. Res., 1, 23 (2014); https://doi.org/10.1016/j.ancr.2014.06.004.

S.B. Bari, P.S. Jain, A.R. Bakshi and S.J. Surana, J. Anal. Bioanal. Techn., 2, 119 (2011); https://doi.org/10.4172/2155-9872.1000119

Issue

Vol. 29 No. 10 (2017): Vol 29 Issue 10

Stability Indicating Method Development and Validation of Finasteride by High-Performance Thin-Layer Chromatography Studies

Corresponding Author(s) : Minal Ghante

Abstract

Keywords

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