Rp-Hplc Method Development And Validation Of Telbivudine In Bulk And Marketed Pharmaceutical Dosage Form

Abstract

 A new, simple, rapid, precise, accurate and reproducible RP-HPLC method forthe estimation of Telbivudine in bulk form and marketed pharmaceutical dosage form. Separation of Telbivudine was successfully achieved on a Symmetry ODS C18 (4.6 x 250mm, 5mm particle size) column in an isocratic mode of separation utilizing Methanol: Phosphate Buffer (35:65% v/v) (pH-3.2 adjusted with orthophosphoric acid) at a flow rate of 1.0mL/min and the detection was carried out at 278nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 30-70mcg/mL for Telbivudine.The correlation coefficient was found to be 0.999 for Telbivudine. The LOD and LOQ for Telbivudine were found to be 0.9µg/mL and 2.7µg/mL respectively. The proposed method was found to be good percentage recovery for Telbivudine, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.