Stability-indicating ultra-fast liquid chromatographic analysis of maprotiline in pharmaceutical formulations

Abstract

Abstract: This current study aimed to develop a simple, fast, and reproducible isocratic reverse-phase ultra-fastliquid chromatographic (RP-UFLC) method to detect and quantify maprotiline hydrochloride (MAP) in bulkdrug and pharmaceutical formulations. Chromatographic separation was accomplished on a C18 column (100 ×4mm, 3 μm) under isocratic elution with the use of a binary solution of acetonitrile and phosphate buffer at a pHof 7 (75 : 25, v/v) and a flow rate of 0.4 mL per minute at 215 nm. The linearity was excellent in theconcentration range of MAP from 0.1 to 1.5 µg/mL with a regression coefficient of 0.9996. The proposedmethod was validated with the respective ICH guidelines. The drug was subjected to hydrolytic, acidic, basic,thermal, photolytic, and oxidative stress conditions as required by the ICH regulation. The method was found tobe suitable for use in routine practice to analyze MAP in the pharmaceutical dosage form.