Validation and Forced Degradation Studies for the Determination of Erlotinib in Bulk and Pharmaceutical Dosage Forms by RP-HPLC

Abstract

A new reverse phase-high performance liquid chromatography (RP-HPLC) have been developed and validated for the determination of Erlotinib in bulk drug and pharmaceutical dosage form. The developed method is rapid, accurate, precise, simple and economical. The separation was carried out using column Hypersil ODS C-18 (150 mm x 4.6 mm 5 μm particle size) in isocratic mode, using mobile phase composition of 0.1% orthophosphoric acid: Acetonitrile in the ratio of 20:80 and P^H adjusted to 4.0±0.1 with 1 M sodium hydroxide. The flow rate was 1.0 ml/min effluents are monitored at 245 nm. Chromatogram showed peak at a retention time of 2.706 min for Erlotinib. The method is validated according to ICH guidelines system suitability, linearity, precision, accuracy, specificity, ruggedness, robustness, LOD and LOQ. The calibration plot showed good linear relationship with r² = 0.999 in the concentration range of 25-150 μg/ml for Erlotinib. The LOD and LOQ were found to be 1.07 μg/ml and 3.24 μg/ml. Accuracy was found to be 99.89%. Erlotinib was also exposed to acidic, alkaline, oxidative, thermal and photolytic conditions and the stressed samples were analyzed by the proposed method. Degradation studies showed that the Erlotinib was highly stable under acidic, alkaline, oxidative, thermal and photolytic conditions without change in RT values compared to standard and no significant degraded peaks were observed. The high percentage of stability under stress conditions confirms the suitability of the method for the determination of Erlotinib in pure and marketed formulations.

Keywords: Erlotinib, RP-HPLC, validation, Forced degradation studies, ICH guidelines

Cite this Article

K. Kalyani, V. Anuradha, Rlc. Sasidhar et al. Validation and Forced Degradation Studies for the Determination of Erlotinib in Bulk and Pharmaceutical Dosage Forms by RP-HPLC. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 44–53p