COST EFFECTIVE, ROBUST PRECISE & STABILITY INDICATING ANALYTICAL METHOD VALIDATION OF RELATED SUBSTANCES FOR PIMECROLIMUS CREAM BYRP-HPLCAbstract
A new, precise, economical and gradient reverse-phase high-performance liquid chromatography (RP-HPLC) method has been validated for the relative substance determination in pimecrolimus cream. The chromatographic separation was achieved with phenomenax luna, C18, 150 x 4.6mm and 3 µm particle size column. The flow rate was 1.5 mL/min and eluents were detected at 210 nm using PDA detector. The retention time of pimecrolimus and desmethyl pimecrolimus was found to be 31.5 min and 27.5 min respectively. The calibration curves were linear for both pimecrolimus and desmethyl pimecrolimus. The LOQ was 0.50μg/ ml for pimecrolimus and 0.47μg/ml for desmethyl pimecrolimus. The approach has been validated in accordance with the international conference on harmonization’s regulatory criteria. The evaluated parameters are precision, linearity, detection limit, quantification limit, specificity, accuracy and robustness. The technique may be applied to stability investigations as well as routine analysis to identify and quantify known and unidentified impurities pimecrolimus in the pharmaceutical dosage form.
Neha Sharma * and Mukesh Kumar Gupta
Faculty of Pharmaceutical Sciences, Lords University, Alwar, Rajasthan, India.
12 January 2023
12 February 2023
18 March 2023
01 April 2023