Stability Indicating Method Development and Validation for Simultaneous Estimation of Mefloquine and Artesunate in Tablet Dosage Form
Journal Title: Scholars Academic Journal of Pharmacy - Year 2014, Vol 3, Issue 5
Abstract
The main objective of this study was to develop a simple, efficient, specific, precise and accurate Stability indicating Reverse Phase High Performance Liquid Chromatographic method for estimation of Mefloquine and Artesunate in tablet dosage form.The chromatographic separation can be done by using reverse phase C18 column; Inert sil ODS (250mm× 4.6mm ×5µm).The mobile phase used was mixture of Phosphate buffer (13.6gm of Potassium dihydrogen Phosphate in 1000ml of water;( pH 4.2) Methanol in the ratio of 40:60(v/v) at isocratic mode and detection of eluents can be done using PDA detector 210-400nm as the detector.The optimized method contains the retention times of Mefloquine and Artesunate at 2.734 and 3.630 respectively with theoretical plate count of 4731 and 7411.The method shows a good linearity in the concentration range of 400-1200µg/ml for Mefloquine and 200-600µg/ml for artesunate with regression co efficient of 0.999 and 1.0 for Mefloquine and Artesunate. The % assay of Mefloquine and Artesunate were 99.10% and 99.70%.The LOD and LOQ were 2.895 and 9.650 µg/ml for Mefloquine and 2.7119 and 9.0395 µg/ml for Artesunate respectively. The % of recoveries of both drugs100%.The proposed stability indicating method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines and hence can be successfully applied to the stability indicating estimation of Mefloquine and Artesunate in tablet formulation. Keywords: Mefloquine, Artesunate, RP-HPLC, Stability indicating, Validation.
Authors and Affiliations
P. Jyothi ,, K. Geetha ,, A. Ajitha ,, V. Uma Maheshwara Rao
Keywords
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