Development and Validation of Analytical Methods for Determination of Antimalarial Drugs Used in Falciparum in their Pharmaceutical Dosage Forms and Bulk

Abstract

ART and LUM were successfully quantified with assay values of 98.34 ± 1.89 for and 101.58 ± 0.43 respectively in range of 1200-7200 ng/spot of LUM and 200-1200 ng/band of ART with 0.997 and 0.995 as value of r2 respectively.. Validation of method was successful as per ICH Q2R1 guidelines. Artemether and arteether were quantified from bulk with assay values of 98.29 ± 1.07 for and 98.31 ± 0.80 respectively, method was extremely quick as elution time was found to be 2.70 and 1.52 for ARM and ARE. Confirmation of stability was achieved by LC-MS studies. Artesunate and Mefloquine hydrochloride were estimated by developed and validated HPTLC with assay values of 100.08 ± 1.69 and 98.22 ± 1.72 respectively. Rf value of eluting components was 0.235± 0.007 and 0.547±0.016. An expeditious RP-HPLC method for establishing concentrations of ARS and MEFLO yielded good assay values of 100.55 ± 0.99 and 101.35 ± 0.11. Elution time was found to be 3.10 and 5.02 minutes for ARS and MEFLO. Linearity of method was in between range of 2-10 and 1.68 µg/ml for MEFLO and ARS with 0.997.as value of r2. HCQ along with impurities were separated and quantified in short run time with incorporation of sodium pentane sulphonate. Elution time was found to be 2.15, 3.88, 5.01, 12.96 minutes for IMP-2, HCQ, IMP-3, IMP-4. Stability of method can be assured as % degradation was within the limits. All the components showed linearity between 10-50 µg/ml .When quantified, assay value were found to be 100.21 ± 1.01, 99.01 ± 1.15, 98.96 ±1.43 and 100.73 ±1.57 % for IMP 2, HCQ, IMP 3 and IMP 4 respectively.