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  • 1 Government of India Indian Pharmacopoeia Commission, Ministry of H. and F.W. Rajnagar, Ghaziabad U.P. 201 002 India
  • | 2 M.M.H. College Department of Chemistry Ghaziabad U.P. 201 001 India
  • | 3 Jamia Hamdard Department of Pharmaceutics, Faculty of Pharmacy New Delhi 110 062 India
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A simple, sensitive, precise, rapid, and reliable HPTLC method for quantitative analysis of artemether and lumefantrine in tablets has been established and validated. The method uses aluminum foil plates precoated with silica gel 60 F 254 as the stationary phase and nhexaneethyl acetate 8:2 ( v/v ) as mobile phase. Bands were scanned at 357 nm, the wavelength of maximum absorption. The method is linear ( r2 > 0.995), precise (RSD < 2%), accurate (average recovery of 100.5% for artemether and 99.5% for lumefantrine), specific, and robust. The artemether content of the tablets varied from 98.50 to 102.45% and that of lumefantrine from 97.80 to 100.64%. The limits of detection and quantification for artemether were 50 and 150 ng per band, respectively, and those for lumefantrine were 300 and 900 ng per band, respectively. The suitability of this HPTLC method for quantitative analysis of artemether and lumefantrine was proved by validation in accordance with the requirements of pharmaceutical regulatory standards. The method was successfully applied to the analysis of a commercial pharmaceutical tablet dosage form. The method is simple, rapid, reproducible, and accurate and is a more effective option than other chromatographic techniques used for routine quality control.

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