Der Pharmacia Lettre
Abstract
Author(s): V.Rajamanickam, B.Stephen Rathinaraj, N.Thangavelpandian,
Ananda Rajagopal Pandian
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 Ã?¢Ã?â?¬Ã?â?? CV C18 (150 X 4.6 mm), using a mobile phase of Sodium acetate buffer
(the pH was adjusted to 3.0 Ã?â??Ã?± 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 at30Ã?â??Ã?°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 Ã?â??Ã?± 1.5%. The method was validated for precision and accuracy. The proposed
method was successfully applied to the pharmaceutical dosage forms containing the abovementioned
drug combination without any interference by the excipients.
