DEVELOPMENT OF RP-HPLC METHOD FOR THE ESTIMATION OF ACOTIAMIDE HYDROCHLORIDE HYDRATE USING AQbD APPROACH

The current studies details QbD enable the development of a simple, rapid, and cost-effective reverse phase high performance liquid chromatographic method for estimation of Acotiamide hydrochloride hydrate. The simple analytical RP-HPLC method was developed using Box-Behnken Design (BBD). In the present work, three independent factors were used, such as org phase (A), aqueous phase (B), and flow rate (C). Totally 17 experimental runs were suggested by the software for analyzing the interaction, and the tailing factor (R1), retention time (R2), and area (R3) were considered as response factors (dependent factors). The developed experimental design was statistically analyzed using ANOVA, counterplots, and surface response curves. The optimal chromatographic separation was achieved using Hyperchrom ODS C₁₈ (4.6×250 mm, 5µ) analytical column with a mobile phase containing potassium dihydrogen phosphate buffer (pH 6.8): Acetonitrile (60:40 v/v) with the flow rate of 1 ml/min using PDA detector. The retention time of the drug was found to be 5.2646 min at a detection wavelength of 282 nm. The method was found to be linear in the concentration range of 2-10 µg/ml.  The method was validated as per the ICH guidelines for precision, accuracy, linearity, ruggedness, robustness, the limit of detection, and limit of quantitation. The proposed method was found simple, economical, and robust, which can be used for routine analysis of the Acotiamide hydrochloride hydrate.