Abstract

N. Appala Raju, J. Venkateswara Rao, K. Vanitha Prakash, and K. Mukkanti¹  

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Gemcitabine hydrochloride in parenteral dosage form. A Hypersil BDS C18, 150 x 4.6 mm, 5 μm particle size, with mobile phase consisting of ammonium acetate in water (0.03M) and methanol was used in gradient mode. The flow rate was 1 ml/min and the effluents were monitored at 268 nm. The retention time was 7.24 min. The detector response was linear in the concentration of 10-120 mcg/ml. The respective linear regression equation being Y=3322.25x+29349.70. The limit of detection and limit of quantification was 0.5 and 1.5 mcg/ ml respectively. The percentage assay of Gemcitabine hydrochloride was 99.22 %. The method was validated by determining its accuracy, precision and system suitability. Conditions were investigated to provide the best peak resolution concerning symmetry & tailing; reduce runtime as proposed advantage& present low cost and simple modus operandi. The results of the study showed that the proposed Gradient RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Gemcitabine hydrochloride in bulk drug and in its pharmaceutical dosage forms.

Gemcitabine hydrochloride; Gradient RP-HPLC; Estimation and Parenterals

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