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.
Method & Results: 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. 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. Forced degradation studies were done to determine the stability of the drug. The developed
method was validated as per ICH guidelines.
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.
Keywords: Erlotinib Hydrochloride, RP-HPLC method, Chemometrics, Nanostructured lipid carriers, Box Behnken design
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