Validation of an HPLC-MS method for rociverine tablet dissolution analysis.

摘要

The aim of this work was to develop and validate a method to assess the dissolution behaviour of rociverine sugar-coated tablets. In our laboratories, an HPLC-MS in reverse phase method of analysis was developed for the dosage of unknown rociverine solution. This analytical method was applied to determine the dissolution rate of rociverine tablets produced by the industrial procedure, because there is no official method description. Dissolution tests were carried out in sink conditions as follows: dissolution medium HCl 0.01 N, paddle rotation speed 50 rpm and vessel volume 1000 ml. The dissolution test gave satisfactory results: 95% of the drug was dissolved within 30 min and drug dissolution was concluded after 60 min. The method was demonstrated to be adequate for Quality Control of rociverine tablets. Validation was inferred from specificity, linearity, precision, accuracy and robustness.