A New Simple Validated RP-HPLC-PDA Analytical Method for Estimation of Aceclofenec in Active Pharmaceutical Ingredients and Bulk Drug Form Used as Anti-Anti-Inflammatory Drug

Abstract

A simple, economical, user-friendly, precise, accurate, robust, rugged and linear analytical method developed and validated for estimation (Assay) of Aceclofenac in Active Pharmaceutical Ingredients or bulk drug form.Isocratic HPLC method developed, flow rate is 1.5 ml/min, and column used Hemochrom C18 Intsil (150mm X 4.6 mm X 5 µm), Column temperature used is 25ºC. Mobile phase used is made from 50 volume of buffer consist of 0.1 % orthophosphoric acid and 50 volumes of organic phase consist of 90% Acetonitrile. The UV detection wavelength is 275 nm. Linearity of the method was observed 50 µg/ml to 150 µg/ml. The retention time of Aceclofenac is ≈ 6.0 minute. This method was validated as per ICH guideline. (1) This method is very user-friendly and can be used for estimation of Aceclofenac in Active Pharmaceutical Ingredients and Bulk drug form because Analytical method validation of this method is successfully achieved in present study.