Validated HPTLC method of analysis for artemether and its formulations.
A simple, sensitive, precise and rapid high-performance thin-layer chromatographic (HPTLC) method of analysis for artemether both as a bulk drug and in pharmaceutical formulations was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene-ethyl acetate-formic acid (8:2:0.3, v/v/v) as mobile phase. Densitometric analysis of artemether was carried out in the reflectance mode at 565 nm. The system was found to give compact spots for artemether (R(f) value of 0.50+/-0.03). The linear regression analysis data for the calibration plots showed good linear relationship with r(2)=0.9904 in the concentration range 200-1000 ng per spot. The mean value of correlation coefficient, slope and intercept were 0.9904+/-0.011, 7.27+/-0.11 and 166.24+/-56.92, respectively. The method was validated for precision, accuracy, recovery and robustness. The limits of detection and quantitation were 65.91 and 197.74 ng per spot, respectively. The method has been successfully applied in the analysis of lipid based parenteral formulations and marketed oral solid dosage formulation.
Tayade
Nitin G
NG
Department of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai 400098, India.
Nagarsenker
Mangal S
MS
D000962:Antimalarials / Q000032:analysis*; D000077549:Artemether; D037621:Artemisinins / Q000032:analysis*; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002855:Chromatography, Thin Layer; D003720:Densitometry; D004655:Emulsions; D007202:Indicators and Reagents; D016014:Linear Models; D008081:Liposomes; D019999:Pharmaceutical Solutions; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D000962:Antimalarials; D037621:Artemisinins; D004655:Emulsions; D007202:Indicators and Reagents; D008081:Liposomes; D019999:Pharmaceutical Solutions; D000077549:Artemether