Central composite design based development and validation of an rp-hplc method for paclitaxel in bulk and pharmaceutical dosage form

Abstract

ObjectiveDevelopment of an accurate, precise, robust, sensitive, economical and rapid isocratic reverse phase high performance liquid chromatography (RP-HPLC) technique complying quality by design (QbD) and validate according to ICH guidelines for the quantitative estimation of Paclitaxel in bulk and pharmaceutical dosage form.MethodThe simultaneous assessment of the Paclitaxel with Nilotanib as internal standard in bulk and pharmaceutical dosage forms with the help of chemometrics, multicriteria decision-making approach. The separation was achieved by utilizing Phenomenex Enable C₁₈ column (Gemini, 15x4.6mm, 5μm particle size) and PDA-UV detection set at 230nm was developed and validation of Paclitaxel in pure form and pharmaceutical formulation, optimized by Derringer’s desirability functions. Chromatographic separation was consisted of a mixture of acetonitrile and KH₂PO₄ (70:30 %v/v, pH 4) adjusted with orthophosphoric acid and the flow rate of 0.8ml/min.Newly developed method resulted in eluting the drug at 3.928min, respectively. The regression coefficients (R²) were observed to be 0.999 for all models. The detection of limits (LOD) was about 9.498ng/ml and quantitation limits (LOQ) were about 31.66ng/ml. The relative standard deviation was observed to be 1.842%. Peak area ratio of the analyte and internal standard was used for the estimation of pharmaceutical formulations.The method was validated by determining its precision, accuracy, and system stability. The results of the investigation demonstrated that the suggested RP-HPLC method is simple, rapid, precise and accurate, which is convenient for the routine determination of Paclitaxel in bulk and pharmaceutical dosage forms.