A simple, novel, accurate, precise, linear, rapid and economical RP-HPLC method was developed for the estimation of tenofovir disoproxil fumarate. The chromatographic separation was achieved using a phenomenex gemini-NX-5 C18 (250 x 4.6 mm, 5 �¼) column and isocratic elution, a mobile phase comprising of Methanol: 0.05mM Phosphate buffer (60:40 v/v) pH 5 was adjusted with O-Phosphoric acid. The flow rate was 1.0 ml/min with detection at 260 nm using a UV detector and drug eluted with retention time of 5.082 min. The calibration curves were linear (r�²=0.9990) in the concentration range of 10-50 �¼g/ml. The limit of detection and limit of quantitation were found to be 0.0616 and 0.1848 �¼g/ml respectively. Thus the simple, novel, economical, accurate, precise and rapid RP-HPLC method was developed for estimation of tenofovir disoproxil fumarate and validated as per ICH guidelines. Hence the method holds good for routine analysis tenofovir disoproxil fumarate in pure and pharmaceutical dosage form.
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