Development and Validation of Difference Spectrophotometric Method for Quantitative Estimation of Gemcitabine Hydrochloride Injection

Gemcitabine hydrochloride is used as an anti-cancer drug. The aim of the present study is to develop difference spectrophotometric method for the estimation of gemcitabine in bulk and lyophilized powder for injection. Difference spectrophotometric method has been developed for quantification of gemcitabine in injection formulation. The method was developed by measuring the difference spectral characteristics of the drug in 0.1N HCL and 0.1N NaOH at absorption maximum of 236nm. Beers law was obeyed in the concentration range of 525μg/ml. The LOD and LOQ were found to be 0.43 and 1.30μg/ml respectively with coefficient of correlation 0.999. The proposed method has been validated for linearity, accuracy and precision as per ICH guidelines and applied for quantitative analysis of gemcitabine hydrochloride injection.