Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ASSAY OF AMLODIPINE IN FORMULATIONS

*B. Balaswami and P. Venkataramana

ABSTRACT

A simple, sensitive and accurate gradient reverse phase high performance liquid chromatography method was developed for determination of amlodipine in formulation. The effective separation was achieved on Phenamex C18, 250 x 4.6 mm, 4.5μm. Mobile was prepared a filtered and degassed mixture of buffer, methanol and acetonitrile in the ratio of 55:35:10. The buffer was prepared by dissolve 7 mL of Triethyl amine in 1000 ml of water, adjust its pH to 3.0 with orthophosphoric acid mix and filter. The flow rate of the mobile phase was 1.2 mL/min and the total elution time was 60 minutes. The UV detection wavelength was carried at 240 nm and experiments were conducted at 30°C. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy and robustness as per the ICH guidelines.

Keywords: Amlodipine, Method development, Validation and RP-HPLC.


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