The Estimation of Gemcitabine Hydrochloride in Parenteral Dosage Forms by Gradient Rp-Hplc

• Published in: Oriental journal of chemistry 2008-01, Vol.24 (1), p.135
• Main Authors: Raju, N Appala, Rao, J Venkateswara, Prakash, K Vanitha, Mukkanti, K
• Format: Article
• Language: English
• Subjects: Ammonium acetate; Dosage; Flow velocity
• ISSN: 0970-020X; 2231-5039

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.