Development and Optimization of Oral Disintegrating Tablets of Esomeprazole Enteric Coated Pellets by QbD Approach

Abstract

The main aim of the present research work was to develop a new simple, precise, selective, accurate and rapid reverse phase high performance liquid chromatographic stability indicating method had been developed and validated for simultaneous quantitative determination of Atorvastatin and cholecalciferol pharmaceutical dosage form especially to get some more advantages over other methods already developed for this combination. Result: Chromatographic separation was carried out on Young lin HPLC (YL Clarity) using C-18 (250 mm × 4.6 mm, 5.0μm) as stationary phase and mobile phase containing Methanol: Water (98:2.0 %v/v) at flow rate of 0.8ml/min using UV detection at 254 nm. The retention time for Atorvastatin and Cholecalciferol was found to be 3.303 and 8.610 min respectively. The method was validated as per ICH guideline and successfully used for the quantitative analysis of commercially available tablet. Atorvastatin and Cholecalciferol were also subjected to stress conditions of acid hydrolysis, base hydrolysis, oxidation andthermal degradation under same chromatographic condition. Conclusions: The optimized assay condition was validated according to International Conference on Harmonisation (ICH) guidelines to confirm specificity, linearity, accuracy and precision. The proposed validated method was successfully applied for the analysis of commercially available pharmaceutical dosage form.