Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR THE DETERMINATION OF AZELNIDIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Girindra Lekhi*, Chandanam Sreedhar, T. Srinivasa Rao, Harsha K. Tripathy, Deepthi D. Kini and Manju S. V.

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Abstract

The new RP-HPLC method for the estimation of Azelnidipine was found out by using different chromatographic parameters. Chromatography was performed by gradient reverse phase separation using a Water’s XBridge C18 column of particle size 5μ 250×4.6mm. The separations were achieved at the UV detection at 255nm using the mobile phase of Potassium dihydrogen phosphate and orthophosphoric acid (buffer): Methanol (60:40v/v). Flow rate was 1ml/min and the injection volume was set at 20 μl with 10 mins of runtime. The retention time was observed at 4.49 mins. The method was validated by using various validation parameters like accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ). These results showed the method could find practical application as a quality control tool for analysis of the drug in its pharmaceutical dosage forms in quality control laboratories. The standard curve was linear over a working range of 5-30 μg/ml and gave an average correlation factor of 0.9984 for Azelnidipine. The limit of detection and the limit of quantitation were found to be 1.38μg/ml μg/ml and 4.17μg/ml respectively. The method showed good recoveries and relative standard deviations of intra and inter day assay less than 2. This method can be easily and conveniently used for routine analysis of Azelnidipine in bulk and tablet dosage forms.

Keywords: Azelnidipine, RP-HPLC, Accuracy, Precision, Linearity, LOD, LOQ.