HPLC Quantification of Aprepitant in Bulk and Capsules

A simple, accurate, and precise Reverse Phase High-Performance Liquid Chromatography (RP HPLC) method has been developed and validated for the quantitative determination of Aprepitant in bulk and pharmaceutical dosage form(capsules). The chromatographic separation was carried out using a C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of Acetonitrile and Phosphate Buffer (pH 3.0 adjusted with 1% orthophosphoric acid) in the ratio of 85:15 v/v. The flow rate was maintained at 1.0 mL/min, and detection was carried out at a wavelength of 264 nm. The retention time of Aprepitant was found to be 3.75 minutes. The method showed good resolution with symmetrical peaks, a tailing factor less than 2, and theoretical plates greater than 2000, indicating high efficiency of the column. Linearity was observed in the concentration range of 200-1000µg/mL, with a correlation coefficient (R²) greater than 0.997, confirming the method's linearity. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 39.63µg/mL and 120.09µg/mL, respectively. The accuracy of the method was confirmed by recovery studies at 80%, 100%, and 120% levels, with results ranging from 100.4% to 103.22% w/w, indicating excellent recovery. The % assay of Aprepitant in Capsule formulation was found to be 99-101.36% w/w, demonstrating that the method is suitable for routine analysis. The developed method was validated in accordance with ICH guidelines (Q2(R1))10 and found to be specific, accurate, precise, robust, and suitable for the routine quality control of Aprepitant in both bulk and pharmaceutical dosage form(capsules).