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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF NIFEDIPINE IN TABLET DOSAGE FORM

Patre Narendra G.*, S. S. Patil and N. Y. Gond

ABSTRACT

A simple and sensitive, HPTLC method has been developed for the quantitative estimation of Nifedipine in it’s single component tablet formulation. The separation was carried out on Merck aluminium plates precoated with silica Gel 60 F254 using n-hexanel:ethyl acetate in the ratio of 6:4: (v/v) as mobile phase. Nifedipine showed Rf value of 0.59±0.027 and was scanned at 254nm using Camag TLC Scanner3. The linear regression data for the calibration plot showed a good relationship with r=0.9892. The method was validated for precision and recovery. The limits of detection and quantification were 20.60 and 40.42 ng/spot respectively. The developed method was successfully used for the assay of nifedipine tablet formulations. The photo degraded product of Nifedipine formed was investigated by Liquid Chromatography mass spectrometer. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.

Keywords: Pharmaceutical analysis, Thin layer chromatography, Antihypertensive drug, Nifedipine.


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