A validated RP-HPLC method of Metoprolol Succinate and Amlodipine Succinate from bulk drugs

By V. Rajamanickam, B. Stephen Rathinaraj, N. Thangavelpandian and Ananda Rajagopal Pandian

ABSTRACT


A simple, rapid and precise method is developed for the quantitative simultaneous determination of Metoprolol succinate and Amlodipine Besylate in a combined pharmaceutical-dosage form. The method is based on High Performance Liquid Chromatography (HPLC) on a reversed-phase column, Inertsil ODS – CV C18 (150 X 4.6 mm), using a mobile phase of Sodium acetate buffer (the pH was adjusted to 3.0 ± 0.05 with Ortho Phosphoric acid), acetonitrile and methanol (80:20 v/v). The buffer used in the mobile phase contains Sodium acetate in double-distilled water. The chromatographic conditions are flow rate of 1ml/min, column temperature at30°C and detector wavelength of 215nm. Both the drugs were well resolved on the stationary phase and the retention times were around 10.3 minute for Metoprolol succinate and 3.8 minute for amlodipine. The method was validated and shown to be linear for Metaprolol succinate and amlodipine. The correlation coefficients for Metoprolol succinate and amlodipine are 0.999963 and 0.999979, respectively. The relative standard deviations for six replicate measurements in two sets of each drug in the tablets is always less than 2% and mean % error of active recovery not more than ± 1.5%. The method was validated for precision and accuracy. The proposed method was successfully applied to the pharmaceutical dosage forms containing the above-mentioned drug combination without any interference by the excipients.

Key words: Reverse phase liquid chromatography, Metoprolol succinate, Amlodipine Succinate, HPLC, specificity, validation.

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