Development and Validation of RP-HPLC Method ...

Development and Validation of RP-HPLC Method for the Estimation of Erlotinib in Its Pharmaceutical Dosage Form

Author Name : Ritika Dixit, Prof. Dr. Praveen Kumar, Ms. Shivani Kala

ABSTRACT The development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the estimation of Erlotinib in its pharmaceutical dosage form is crucial for ensuring drug quality, efficacy, and safety. Erlotinib, a tyrosine kinase inhibitor, is widely used in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. Therefore, the establishment of a precise, accurate, and validated analytical method is essential for routine quality control and regulatory compliance. This review provides an in-depth discussion on the systematic approach to RP-HPLC method development, covering critical aspects such as chromatographic conditions, mobile phase selection, and optimization of parameters like pH, flow rate, and detection wavelength. Various trials were conducted to achieve the best possible resolution, peak shape, and retention time, ensuring the method's suitability for quantitative analysis. Furthermore, method validation was performed in accordance with International Council for Harmonisation (ICH) guidelines, assessing key parameters such as specificity, linearity, precision, accuracy, robustness, and detection limits. The results confirmed the method's capability to separate Erlotinib from potential impurities, degradation products, and excipients with high reproducibility and reliability.