A simplified HPLC method for quantification of torsemide from human plasma and its application to a bioequivalence study.
A simple, rapid and selective method was developed. The method was validated and found to be linear in the range of 100-4000 ng/ml. Chromatographic peaks were separated by means of a 5 mum, C18 silica column using acetonitrile and phosphate buffer (0.05 M) in proportion of 40:60 (pH 4.0) as a mobile phase. The retention time of torsemide was 5.00+/-0.20 min. The chromatograms showed good resolution and no interference from plasma. The mean recovery from human plasma was found to be above 82%. Both inter-day and intra-day accuracy and precision data showed good reproducibility. This method was applied to a single dose bioequivalence study. Log transformed values were compared by ANOVA followed by classical 90% confidence interval. Confidence limits for C(max), AUC(0-t) and AUC(0-inf) ranged from 98.6 to 102.8, 101.8 to 105.3 and 102.4 to 105.5 respectively. These results suggested that the analytical method was linear, precise and accurate. Test and reference product were found to be bioequivalent.
Khan
I J
IJ
Department of Pharmacology, The Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai-400 098, India.
Loya
P
P
Saraf
M N
MN