A Novel RP HPLC Method for Development and Validation of Cilnidipine In Bulk and Pharmaceutical Dosage Form


Volume :

5

Issue :

3

Abstract :

A simple, Precise, accurate RP-HPLC method was developed and validated for the estimation of cilnidipine in pharmaceutical dosage forms. separation was achieved on Symmetry C18 column (4.6 x 150mm), with mobile phase consisting of ortho phosphoric acid buffer pH 4 and Acetonitrile in 60:40, V/V. The flow rate was maintained at 1 ml/min and the analyte was monitored at 240nm wavelength. The retention time for cilnidipine was found to be 2.35 min. The linearity of the method was observed in the concentration range of 5-25ppm and correlation coefficient was found to be 0.999. The percentage assay of Cilnidipine was found to be 98.733%. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in flow rate and analysis being performed on different days. The method was validated for its accuracy, precision and system suitability. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the routine estimation of Cilnidipine in pharmaceutical dosage forms.

Keyword :

Cilnidipine, RP- HPLC, Validation etc.