Abstract

DEVELOPMENT AND VERIFICATION OF RP-HPLC METHOD FOR THE QUANTITATIVE DETERMINATION OF DECITABINE IN TABLET DOSAGE FORMULATION

Chinnam Naidu Botta*, Putchakayala Purnachandra Rao, Rajesh Vooturi, Biswal Devraj and Niroop Lakkapatri

ABSTRACT

Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved by using YMC Triart C18, 250 x 4.6mm, 5μm (Part No. TA12S05-2546WT) column. The mobile phase consists of gradient elution using of mixture of 0.02M Potassium dihydrogen phosphate buffer and Methanol in the ratio of 97:3 as Mobile phase A and Water and Acetonitrile in the ratio of (40:60) as Mobile phase B . The flow rate is 1.5 mL/min, injection volume is 5 μL, the column temperature is 30°C and the detection is by UV at 242 nm. The retention time of decitabine was found about 6.6 minutes. The linearity of this method was found in the concentration range of 50-150μg/mL. The correlation coefficient R2 value is found to be 1.000. This method was found to be good percentage recovery about 100.5 % 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 verified according to ICH guidelines for Linearity, Range, Accuracy, Precision, specificity and Robustness.

Keywords: Decitabine tablets, Development, Verification, HPLC, ICH, Antineoplastic.