DEVELOPMENT AND VALIDATION METHOD FOR DECITABINE INJECTION BY RPHPLCAbstract
A new, precise, rapid, accurate RP-HPLC method was developed for the estimation of Decitabinein pharmaceutical dosage form. After optimization the good chromatographic separation was achieved by Isocratic mode with a mixture of Ammonium Acetate buffer of pH 4.5: Acetonitrile (985:15) v/v as the mobile phase withDevelosil Rp Aqueous-AR-5 (150 x 4.6 mm, 5 µm), column as stationary phase at flow rate of 1.5 mL/min and detection wavelength of 244 nm. The Retention time of decitabine was found to be 3.796 min. The linearity of this method was found in the concentration range of 50-150 µg/mL. The correlation coefficient R2value is found to be0.998. The LOD for this method was found to be 0.0003 µg/mL. The LOQ for this method was found to be 0.0009 µg/mL. This method was found to be good percentage recovery about 99.77 indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of formulation. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, specificity and Robustness.
Sunilkumar Adupa*, K. Satish and J. Ravi
Department of Pharmaceutical Analysis & QA 1, Vikas College of Pharmaceutical Sciences, (V) Rayanigudem, (M) Suryapet, Nalgonda (District) 508376, Andhra Pradesh, India
18 February, 2014
04 April, 2014
15 June, 2014
01 August, 2014