DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ARTEMETHER AND LUMEFANTRINE IN BULK AND PHARMACEUTICAL DOSAGE FORMAbstract
A simple, sensitive, specific, precise, and accurate stability-indicating reverse phase liquid chromatographic method was developed to simultaneously determine Artemether and Lumefantrine in bulk drugs and pharmaceutical formulations. The chromatographic analysis was performed by Microsorb MV100-5 C-18 column (250 x 4.6mm, 5 µm), with a mobile phase consisting of buffer and acetonitrile in the ratio of 65:35v/v, orthophosphoric acid used as a buffer (pH 3.5), at a flow rate of 1 ml/min and eluents monitored at 254nm. The method was validated for linearity, accuracy, precision, robustness, and application for assay as per ICH guidelines. The retention times of Artemether and Lumefantrine were 2.67 and 4.62 min, respectively. The calibration curves of peak area versus concentration, which were linear from 530µg/ml for Artemether and 60-210µg/ml for Lumefantrine had a regression coefficient (r2) greater than 0.999 & precise (R.S.D. < 2.0%). The method had the requisite accuracy, precision, and robustness for simultaneous determination of Artemether and Lumefantrine in tablets.
Bakhshi Abdul Rahman *, Masood Siddiqui, Patil Shivam Ravindra, Saba Fatema Raheel Ahmed and Rahmani Taskeen Firdaus Aasif Iqbal
Royal College of Pharmaceutical Education and Research, Abdul Muttalib Campus, Malegaon, Nashik, Maharashtra, India.
24 November 2021
10 January 2022
06 May 2022
01 July 2022