High-performance liquid chromatography assay for indorenate in pharmaceutical powders

A high-performance liquid chromatographic (HPLC) method for quantification of indorenate admixed of pharmaceutical excipients (Pharmatose DCL 21, Povidone USP and Helmcel 200) is described. Indorenate was extracted from the mixtures using a mobile phase composed of acetonitrile and a sodium acetate buffer solution 0.1 M (63:37) and separated from other dissolved components by ion supression-HPLC. The method was standardized using a C-18 column (250 mm x 4.8 mm, i.d., 5 microns). The photometric detector was fixed at 228 or 272 nm depending on the admixed excipients. Validation parameters included linearity, precision, accuracy, reproducibility, and specificity. The method was specific, selective, and capable to distinguish indorenate from their degradation products and the antihypertensive pelanserine.