ANALYTICAL METHOD DEVELOPMENT & VALIDATION OF ARTEMETHER IN BULK DRUG BY RP- HPLC METHOD AS PER ICH GUIDELINES
Objective: An accurate, precise, rapid & economical RP-HPLC method was developed for the estimation of Artemether as per International Conference on Harmonization (ICH) guideline in pharmaceutical dosage form using ultraviolet (UV) detector.
Methods: Elution was carried out using a mobile phase consisting of Acetonitrile & Methanol (50:50 v/v) and the flow rate was set to 1.6 ml/min at 216 nm, retention time for Artemether was found to be 1.330 min.
Results: The method was found to be linear in the concentration range of 100-600 Âµg/ml, in the linearity study regression equation was found to be y = 0.199x â€“ 1.133 & correlation coefficient was found to be 0.999. This method was Rugged and Robust in different testing criteria, LOD and LOQ were found to be 23.037Âµg/ml, 69.809Âµg/ml respectively. Accuracy study was done in 3 different concentration level i. e 50, 100, 150% & % recovery of the method was found to be 99.4%, 100.4%, 99.7% respectively in 3 different levels & mean recovery was 99.8%, so method was accurate.
Conclusion: Results of all validation parameters were within the limits as per ICH guidelines.
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