Analytical method development and validation for Estimation of Calcium Dobesilate and Docusate Sodium in Pharmaceutical dosage form with QbD approach

Abstract

Analytical method development and validation for estimation of Calcium Dobesilate and Docusate Sodium in Pharmaceutical dosage form with QbD approach. Combination of Calcium Dobesilate and Docusate Sodium helps for the treatment of Haemorrhoid. There is no any UV spectroscopy method of this combination due to less absorbance of the Docusate Sodium in various solvent. A specific, precise and accurate RP-HPLC method has been developed and validated for estimation of Calcium Dobesilate and Docusate Sodium in Capsule dosage form. Apply QbD approach by using statistical tool Design of experiment with Box-Behnken design for the optimization of the screening method of RP-HPLC method. Calcium Dobesilate and Docusate Sodium were estimated on Thermoscientificsyncronis C18 (250mm X 4.6mm), 5μm column using Acetonitrile: 0.01M Tetrabutylammonium dihydrogen phosphate pH-4.8(66:34, v/v) as mobile phase with flow rate 1.0 ml/min and detection was carried out at 214 nm. The retention time of Calcium Dobesilate and Docusate Sodium were found to be 2.943 min and 4.190 min respectively. The linearity and range was found to be 50-450 μg/mL for Calcium Dobesilate and 10-90μg/mL for Docusate Sodium. % RSD of precision was found to be less than 2%. %RSD for Robustness parameters was found to be less than 2%. % Recovery of Calcium Dobesilate and Docusate Sodium at different levels were found in the range of 99.451% - 100.082% and 98.071% - 101.187% respectively. So, the developed method was precise, robust and accurate. The assay value for Calcium Dobesilate and Docusate Sodium was found to be 99.772% - 99.874% and 98.159% - 98.736% respectively.