Development and validation of reversed phase HPLC method for quantification of water insoluble API

ABSTRACT

In the present work a specific, accurate, precise, and reproducible UV-HPLC method was developed and validated for the analysis of Aceclofenac. This method involved elution of Aceclofenac in a mobile phase which is composed of buffer pH 6.8 [i.e. using 0.01N KH2PO4] and HPLC grade Acetonitrile [6040]. Separation of the analyte was achieved using HPLC isocratic pump attached to the UV-VIS detectorC18, guard column and C18 column. The injection volume was 20 micro L, detected at 274 nm; flow rate 1mL/min. Standard calibration curve was measured and found linear from 0.1 to 40 micro g/ml. The validation parameters were measured according to FDA guidelines and successful results were obtained. The presented analytical method could be employed for pharmacokinetic studies