DEVELOPMENT AND VALIDATION OF ISRADIPINE IN BULK AND IN ITS PHARMACEUTICAL FORMULATION BY RP-HPLC METHOD
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 9
Abstract
A simple, sensitive and selective RP-HPLC method for the estimation of Isradipine in pharmaceutical formulation was developed and validate in the present work. Chromatographic separation of drug is performed with kromasil c18 column having internal diameter 100mmX4.6 mm and 5µm diameter and the mobile phase consisting of a mixture of water , methanol and tetrahydrofuran(50:40:10, v/v/v), Isocratic elution at a flow rate of 1.4 ml/min with UV detection at 330nm at 25˚c is used in this method. The proposed RP-HPLC method is successfully applied for the determination of isradipine in pharmaceutical dosage form. The validation studies are carried out and it’s fulfilling ICH requirements.The method is found to be specific, linear, precise (including both intra- and inter- day precision), accurate and robust. The proposed method was successfully applied for the quantitative determination of Isradipine in tablet formulation.
Authors and Affiliations
Laxmi Aswini, D. Dachinamoorthy. Ravi Babu, Lakshmi Surekha, Kumara Swamy
Keywords
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