ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES OF GEMCITABINE NIOSOMES

Gemcitabine hydrochloride niosomes were developed in our laboratory in an effort to improve the efficacy of the drug via development of nanotechnology based delivery system. As a part of this exercise, an analytical method was developed and validated to evaluate the developed formulation for assay and release profile studies. A simple, precise, specific and rapid high performance liquid chromatographic method was developed for determination of gemcitabine hydrochloride in niosomes. The developed method exhibited good resolution, short run time and low cost of analysis. The chromatographic analysis was carried on a Waters® (C18, 250 mm x4.6 mm, 5µ) column using water: acetonitrile (95:5 v/v) as the mobile phase, flow rate of 1.2 ml/min and detection at 268 nm. The robustness of the method was evaluated using design of experiments. The validation studies of the developed method were conducted as per ICH guidelines Q2 (R1). The results indicated that the developed method as specific, accurate, precise, reliable, robust, reproducible, and suitable for the quantitative analysis of gemcitabine hydrochloride in the developed niosomes.