Development and Validation of HPLC Method for Determination of Degradation Impurities for the Qualification of Mebevrine HCl

[摘要] Reverse phase high performance liquid chromatographic method for the estimation degradation impurities of Mebeverine HCl in bulk drug is illustrated. The method consists of; Mobile phase B: Acetonitrile and Mobile phase A: 0.051 M Phosphate buffer (pH-4.5) in gradient pump mode. A linear response was observed in the range of 0.8 to 48 µg/ml with a regression coefficient of 0.999 for both Mebeverine HCl and Veratric acid. The force degradation study was performed to determine the degradation pathways which also proves the specificity of the method. The method is cost effective as well as sensitive. Validation parameters were carried out as per the guidelines of International Conference for Harmonization.

[学科分类] 药学

[关键词] HPLC;Mebeverine HCl;Veratric acid;Validation and Method development.