A Dissolution method with high performance liquid chromatography (HPLC)
analysis was validated for perindopril erbumine and indapamide in combination
tablet formulation. The method was validated to meet requirements for a
global regulatory filing and this validation included specificity, linearity,
accuracy, precision, range, robustness and solution stability studies. The
dissolution method, which uses USP apparatus 1 with basket rotating at 100
rpm, 1000 ml of phosphate buffer pH 6.8 as the dissolution medium, and
reversed-phased HPLC was carried out at 50?C on a 4.6mm?250mm 5?m cyano
column that contained USP packing L1 with acetonitrile: buffer pH 2.8::40:60
(v/v), as mobile phase. UV detector was set at 225 nm. A method was found to
be selective, linear, accurate and precise in the specified ranges. Intra-day
and inter-day variability for method was <2% RSD. This method was
successfully used for quantification of perindopril erbumine and indapamide
combination tablet formulations.