Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Antihypertensive Drug in Bulk and Pharmaceutical Dosage Form

Abstract

Analysis of any product is very important to assure the quality of product followed by safety and efficacy. Its play very important role in the medicinal field. To assure desire quality of the product analysis is very important. Few spectrometric method and chromatographic method have been reported for the determination of Nicardipine HCL in single dosage form.Following method have been developed for the determination of Nicardipine HCL. Analytical Method Development and Validation of Calcium Channel Blocker in Bulk and Pharmaceutical Dosage Form. A new RP-HPLC method was developed for the assay of Nicardipine HCL pharmaceutical dosage form. The separation was achieved by using C18 Hypersil BDS (250x4.6 mm, 5µm) column by using MeoH: ACT: H2O as a mobile phase with the flow rate 1.0ml/min. Where detection was carried out by wavelength at 242nm. The retention time was found to be 15min.The system suitability test shows the response with Retention time, Theoretical plate, Tailing Factor and peak area. Validation of the proposed method was carried out according to ICH guideline. The method developed for quantitative determination of Nicardipine HCL is rapid, precise, accurate and selective. The method was completely validated showing satisfactory data for all method-validated parameters tested. The developed method is stability indicating and can be used for assessing the stability of Nicardipine HCL as bulk drugs. The developed method can be conveniently used for the assay determination of Nicardipine HCL in bulk drugs and pharmaceutical dosage form. The developed method can be conveniently used for dissolution of tablets of the pharmaceutical dosage forms containing Nicardipine HCL in quality control.