Development and validation of an HPLC method for the simultaneous determination of artesunate and mefloquine hydrochloride in fixed-dose combination tablets
BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES(2013)
Abstract
The present study developed and validated an HPLC method for the simultaneous determination of artesunate (AS) and mefloquine hydrochloride (MQ) in fixed-dose combination tablets, according to ICH guidelines. The chromatographic separation was carried out on an XBridge C18 (250 x 4.6 mm i.d., 5 mu m particle size, Waters) analytical column. The mobile phase included a 0.05 M monobasic potassium phosphate buffer (pH adjusted to 3.0 with phosphoric acid) and acetonitrile (50 + 50, v/v). The flow rate was 1.0 mL/min, and the run time was 13 minutes. A dual-wavelength approach was employed: AS detection was performed at 210 nm and MQ was detected at 283 nm, using a diode array detector. Stability of sample solutions was evaluated for 8 hours after preparation, during which time the solutions remained stable. Youden's test was employed to evaluate robustness. The method proved to be linear (r(2)>0.99), precise (RSD< 2.0%), accurate, selective, and robust, proving to be appropriate for routine drug quality control analysis.
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Key words
Artesunate/determination,Mefloquine hydrochloride/determination,High performance liquid chromatography/qualitative analysis,Fixed-dose combination tablets/qualitative analysis
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