Abstract

S. Vidyadhara, R. L. C Sasidhar*, B.Venkateswara Rao, T. Saibabu and D. Lakshmi Harika

DOI : http://dx.doi.org/10.13005/ojc/320168

The present study describes the development and validation of stability indicating RP - HPLC method for the estimation of nelarabine, a chemotherapydrug. Nelarabine was subjected to stress studies under different conditions as per ICH guidelines. The separations were carried out using C18 Reverse Phase Column (CosmicsilAdge 150 x 4.6 mm, 5µm) employing 0.01 % trifluoroacetic acid and acetonitrile (85:15 v/v) as mobile phase at a flow rate of 1.0 mL/min. The wavelength detection was at 266 nm. It was found that nelarabine degrades in alkaline and oxidative conditions, while negligible degradation was observed in acidic, photolytic and thermal conditions. Analytical validation parameters such as specificity, linearity, accuracy, precision were calculated and the relative standard deviation for all the parameters was less than 2%.

Nelarabine; RP – HPLC; stress studies; ICH guidelines; Analytical validation

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