Development and Validation of Dissolution Test Method for Andrographolide from Film Coated Polyherbal Tablet Formulation

The objective of present study was to develop and validate a dissolution test for polyherbal hepatoprotective tablets containing andrographolide with bio-relevant media. Different dissolution conditions such as basket (type I)/paddle (type II) agitation, rotation speed, dissolution medium and volume were evaluated. The dissolution samples were analyzed and validated using a high-performance liquid chromatographic method (HPLC). The separation of the analyte from sample matrix was achieved using an Inertsil RP-18 column with UV detection at 226 nm. Thorough validation of the assay based on pre-defined criteria included specificity, accuracy, precision, linearity and robustness. In addition, filter suitability, standard and sample solution stability was also demonstrated. The best dissolution profile was obtained using type II (paddle) at 75 rpm, 900 ml of medium with pH 4.5 where over 80% of andrographolide was dissolved after 120 min. The method showed specificity, accuracy, precision, linearity and robustness within the acceptable range. Both the HPLC and dissolution method were validated and could be proposed as a pharmacopeial standard to assess the performance of polyherbal formulations containing andrographolide.