Development and Validation of an RP-HPLC Method for Gefitinib in Bulk and Pharmaceutical Dosage Forms using Central-Composite Design

Abstract

Abstract:

Objective: Development of an accurate, sensitive, precise, robust, economical and quick isocratic reverse-phase high-performance liquid chromatography (RP-HPLC) method complying quality by design (QbD) and authorize as per ICH guidelines for the quantitative evaluation of Gefitinib in bulk and pharmaceutical dosage form.

Method: The simultaneous estimation of the Gefitinib with Sorafenib as an internal standard in bulk and pharmaceutical dosage forms by the assistance of chemometrics, multicriteria decision-making approach. The separation was accomplished by utilizing/with Phenomenex Enable C₁₈ column (15x4.6mm, 5µm particle size); and PDA-UV detection set at 250nm was developed and validated Gefitinib in pure form as well as pharmaceutical formulation, optimized by utilizing/with Derringer’s desirability functions. The mobile phase used for the separation was a mixture of Acetonitrile and Phosphate buffer (30:70 %v/v) and the pH 3, which was adjusted with ortho-phosphoric acid, the flow rate was 1.6 ml/min.

Result: Newly developed method resulted an elution time of the drug at 3.264 min. The regression coefficients (R²) were observed to be 0.999 for all models. The detection (LOD) and quantification limits were 10.47 mg/ml, and 31.74 mg/ml, respectively. The relative standard deviation was calculated as 0.4412%.

Conclusion: Method developed and validated by determining its precision; accuracy; and system stability. The results of the study demonstrated that the planned RP-HPLC method is simple; rapid; precise; and accurate, which is helpful for the analysis of Gefitinib in bulk as well as pharmaceutical dosage forms.

Keywords: Chemometrics, RP-HPLC, RSM, Tyrosine kinase inhibitors, Gefitinib, Sorafenib.

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