The Estimation of Paclitaxel in Parenterals by RP-HPLC.

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Paclitaxel in Parenterals dosage form. A Unison US C18, 250x4.6 mm i.d, 5 μm partical size, with mobile phase consisting of Methanol and 0.02 M potassium dihydrogen phosphate in water (pH 2.5 adjusted with o-phosphoric acid) in the ratio of 80:20 v/v was used. The flow rate was 1 ml/min and the effluents were monitored at 225 nm. The retention time was 4.978 min. The detector response was linear in the concentration of 15–180 mcg/ml. The respective linear regression equation being Y= 46411.83x+29.2578. The limit of detection and limit of quantification was 0.03 and 0.09 mcg/ml respectively. The percentage assay of Paclitaxel was 99.09%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Paclitaxel in bulk drug and in its pharmaceutical dosage form.