Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR THE SIMULTANEOUS ESTIMATION OF METOPROLOL SUCCINATE, CHLORTHALIDONE AND CILNIDIPINE IN TABLET DOSAGE FORM

Harshkumar B. Pandya* and Dr. Parula B. Patel

ABSTRACT

UV-Spectroscopic and RP – HPLC methods for simultaneous estimation of Cilnidipine, Chlorthalidone and Metoprolol succinate in tablet dosage form was developed and validated. In UV- Spectrophotometric method, Absorbance was measured at 241.62 nm for Cilnidipine, 239.72 nm for Chlorthalidone and 342.11 nm for Metoprolol succinate; after making ratio using Chlorthalidone (2.5 μg/ml) + Metoprolol succinate (10 μg/ml), Cilnidipine (2 μg/ml) + Metoprolol succinate (10 μg/ml) and Cilnidipine (2 μg/ml) + Chlorthalidone (2.5 μg/ml) as devisor, respectively and then first order derivative was taken. Ratio spectra derivative spectroscopic method was developed with linearity range of 2 – 6 μg/ml, 2.5 – 7.5 μg/ml and 10 – 30 μg/ml for Cilnidipine, Chlorthalidone and Metoprolol succinate respectively. In RP-HPLC method for Cilnidipine, Chlorthalidone and Metoprolol succinate, chromatographic separation was carried out on Waters spherisorb®, 5μm, ODS (250mm L × 4.6mm Ø) column using mobile phase mixture comprising a Methanol : Acetonitrile : 0.05 M Phosphate buffer (pH 6.5) 10: 80 : 10 % v/v/v and flow rate 1.0 ml/min at 224 nm. RP-HPLC method was developed with linearity range of 2 – 10 μg/ml, 2.5 – 12.5 μg/ml and 10 – 50 μg/ml for Cilnidipine, Chlorthalidone and Metoprolol succinate respectively. Validations of developed methods were performed according to ICH Q2 (R1) guideline.

Keywords: RP-HPLC, UV Spectroscopy, ratio spectra derivative spectroscopic method, Cilnidipine, Chlorthalidone, Metoprolol succinate.