Development and validation of reversed phase high-performance liquid chromatography method for estimation of lercanidipine HCl in pure form and from nanosuspension formulation.

AIM: Quantitative estimation of lercanidipine HCl in bulk material as well as from nanosuspension formulations via a developed reverse phase HPLC method.

MATERIALS AND METHODS: Optimized chromatographic condition was used to achieve separation on a Kromasil (100-5c18 250 × 4.6 mm) column using Shimadzu HPLC system. The mobile phase consisted of a mixture of acetate buffer (20 mM pH 4.5) and acetonitrile in the ratio of 10:90, v/v. It is pumped through the chromatographic system at a flow rate of 1 ml/min. The detection was carried out at 240 nm using ultraviolet-visible spectrophotometry detector. The method was validated as per Q2 (R1) guidelines, and suitability of the developed method was established by optimized nanosuspension formulation.

RESULTS: The method is specific to lercanidipine (RT: 7.7 min), and has ability to resolve the analyte peak from excipient interferences. It is linear (regression coefficient: 0.9993), accurate (average recovery: 100%), and passed all the system suitability requirements.

CONCLUSION: Developed method was found applicable for evaluation of drug content, content uniformity, and analyzing samples of dissolution studies of nanosuspension.