Novel Stability Indicating RP-HPLC Coupled with PDA Detection for the Simultaneous Quantification of Artesunate and Amodiaquine in Bulk and its Tablet

Abstract

Background: The present research paper reports the development of novel, stable and validated RP HPLC method for the simultaneous estimation of Artesunate (ATS) and Amodiaquine (AMDQ) in bulk and tablet dosage form. Methods: Good chromatographic separation was achieved by isocratic mode with a mixture of Phosphate Buffer: Methanol in the ratio of 60: 40 as mobile phase with waters symmetry Shield Rp18Column (250 mm x 4.6mm) and 5 micron particle size as stationary phase at flow rate of 1.0 mL/min. The detection was performed at 223 nm. Retention times for ATS and AMDQ were found 3.6 and 1.5 min respectively. Results: The proposed method showed good intra-day precisions (%RSD=0.36 for ATS, 0.50 for AMDQ), highly accurate (recovery for both ATS and AMDQ>99%) and satisfactory correlation coefficient (R2= 0.9914 for ATS and 99.38 for AMDQ). The detection and Quantitation limit were 0.53 μg/mL and 0.48 μg/mL for ATS, 1.23 μg/mL and 1.78 μg/mL for AMDQ. The percentage recovery in forced degradation study using acid, base, oxidation, photolytic, thermal and neutral conditions shows satisfactory and indicates well separation of both the drugs with other degradation products and the developed method also found good solution stability. Conclusion: Therefore, the present method was found stability indicating untroubled method ever developed, useful for the routine analysis of both the mentioned drugs in bulk as well as tablet dosage form.