Analytical Method Development and Validation for The Determination of Erlotinib in API Form and Marketed Pharmaceutical Dosage Forms By RP-HPLC (Research Article)

Author(s): A. Bheema Naik*, Sundus Fatima Huda, Santhosh Illendula and Ch. V. Suresh, and K.N.V Rao

Abstract: A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Erlotinib in bulk form and marketed formulation. Separation of Erlotinib was successfully achieved on a Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol: Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. 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 12-28mcg/mL for Erlotinib. The correlation coefficient was found to be 0.9995 for Erlotinib. The LOD and LOQ for Erlotinib were found to be 5.004μg/mL and 15.164μg/mL respectively. The proposed method was found to be good percentage recovery for Erlotinib, 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.

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