Original Articles: 2015 Vol: 7 Issue: 1
Analytical method development and validation of lumefantrine in its bulk dosage form by using RP-HPLC method as per ICH guidelines
An accurate, precise, rapid & economical RP-HPLC method has been developed for the estimation of Lumefantrine as per ICH guideline in pharmaceutical dosage form using ultra violet (UV) detector. Elution was carried out using a mobile phase consisting of Acetonitrile & Methanol (90:10) and flow rate was set on 1.6 ml/min at 235 nm, retention time for Lumefantrine was found to be 1.770 min. The method was found to be linear in the concentration range of 100-500 μg/ml, in the linearity study regression equation was found to be y = 97.17x - 3.660 & correlation coefficient was found to be 0.999. This method was Rugged and Robust in different testing criteria, LOD and LOQ was found to be 10.0 μg / ml & 30.5 μg / ml respectively. Accuracy study was done in 3 different concentration level 50, 100, 150% & % recovery of the method was found to be 100.2%, 100.9%, 100.2% respectively in 3 different levels & mean recovery was 100.4%, so method was accurate. Results of all validation parameter was within the limit as per ICH guideline. So this method can be used for the determination of Bulk Drug as well as Tablet Dosage form easily and the method was precise, economical, and accurate to perform in future.