Chemometric Approach to Develop and Validate RP-HPLC Method for Estimation of Erlotinib Hydrochloride in Nano Structured Lipid Carriers

Abstract

Background: Erlotinib hydrochloride is a novel drug for the treatment of lung cancer. Objective: The objective of the present study was to design an uncomplicated and precise reverse phase high-performance liquid chromatography (RP-HPLC) method and optimize the chromatographic parameters using response surface methodology derived from Box Behnken design. The optimized method was validated for estimating Erlotinib from bulk and nanostructured lipid carriers (NLCs) formulation. Methods: Independent variables such as flow rate, injection volume and strength of the buffer were optimized in order to decrease retention time and curtail asymmetry factor of Erlotinib. Forced degradation studies were done to determine the stability of the drug. The developed method was validated as per ICH guidelines. Results: The optimized strength of ortho-phosphoric acid buffer by blending with Acetonitrile (80:20 v/v), flow rate and injection volume were found to be 25mM, 1ml/min, 20µL respectively. Linearity was observed in the concentration range of 1-6 µg/mL. The retention time of Erlotinib was found to be 3.717 minutes. The limit of detection and limit of quantification for Erlotinib were found to be 0.01ng/ml and 1ng/ml, respectively. Conclusion: The proposed method was found to be a simple and the best method for analysing Erlotinib in nanostructured lipid carriers. Chemometric approach was employed as an effective tool for optimising the chromatographic conditions of the proposed method.