Abstract

A STABILITY INDICATING STUDY FOR QUANTITATIVE ESTIMATION OF NIMODIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

R. Swetha Sri*, Dr. K. Bhavya Sri, Amtul Afreen and Dr. M. Sumakanth

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Abstract

A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Nimodipine in API and pharmaceutical dosage form dosage form. The chromatographic method was standardized using Phenomex ODS C18 (250mm x 4.6mm i.d, 5µm) column with UV detection at 237 nm. Method was optimized using methanol:water in the ratio of 60:40as mobile phase at a flow rate of 0.8 ml/ min.Various forced degradation studies like acid, base hydrolysis, peroxide, photolytic degradation were performed on Nimodipine API. The method was fond to be linear over the range of 2g/ml to 12g/ml. The recovery was in the range of 98% to 100% and limit of detection was found to be 0.13 µg/ml and quantification was found to be 0.40 µg/ml.

Keywords: RP-HPLC, Nimodipine (NMD), Method development, validation, ICH Guidelines.