Reversed‐Phase Analytical Method for Enantioselective Analysis of Ormeloxifene Hydrochloride: Application to Bulk Drug and Quality Control Analysis

ABSTRACT The article reports simple, rapid, and novel enantioselective reversed‐phase high‐performance liquid chromatography (RP‐HPLC) for separation of (−)‐(3 R , 4 R )‐ormeloxifene hydrochloride ( d ‐ORM) and (+)‐(3 S , 4 S )‐ormeloxifene hydrochloride ( l ‐ORM) (ORM, centchroman) using chiral stationary phase (Chiral‐AGP, Chiracel OJ‐RH, and ChiraDEX HR). The best enantiomeric separation was obtained on the ChiraDEX HR ( α = 0.89, R s = 1.9) column with a gradient mode elution using a combination of ammonium acetate (10 mM, pH 4.0) and methanol as a mobile phase. The flow rate and column oven temperature were 0.7 mL/min and 30°C, respectively. The detection limits ( λ max 280 nm) for d ‐ORM and l ‐ORM were 0.170 and 0.169 µg/mL, whereas quantification limits were 0.516 and 0.512 µg/mL. The method was validated according to the International Council on Harmonization (ICH) regulatory Guidelines Q 2 ( R 1) in terms of its accuracy, precision, sensitivity, linearity, specificity, robustness, and solution stability. The designed analytical method could be extended as a quality control tool for pharmaceutical quality assessments as well as isomeric quantification of ORM in industrial bulk manufacturing.