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Development and Validation of a New RP-HPLC Method for the Determination of Aprepitant in Solid Dosage Forms
Abstract
Purpose: To develop and validate a new, simple, sensitive, rapid, cost-effective and accurate reverse phase-high performance liquid chromatography (RP-HPLC) method for the determination of aprepitant (APT) in capsule dosage form.
Methods: The method developed for the determination of APT in capsule formulation involved using RP-HPLC which incorporated a C18 column 250 x 2.5 mm i.d, 5 μm particle size, in isocratic mode, with mobile phase comprising of methanol: water in the ratio of 90:10 (v/v). The flow rate was 1 mL/min and the detection was monitored at 220 nm. The total run time was 10 min and the column was maintained at ambient temperature.
Results: APT was eluted in the given mobile phase with a retention time (tr) of 4.473 min. The linearity for the quantification of APT was 0.1 - 10 μg/mL (R2 =0.989, Y= 33032x + 71501) with coefficients of variation (based on mean peak area for six replicate injections) in the range 0.04 to 0.132. The limits of detection and of quantification were 0.028 and 0.094 μg/mL, respectively. Recovery of the method was 99.56 - 100.5 % while the relative standard deviation (RSD) of intra-day and inter-day precision was 0.85 and 1.05, respectively. System precision and method precision were 0.013 and 1.400 %, respectively. The specificity data of the proposed method indicated that excipients in the capsules did not interfere with the drug peak. Furthermore, the well-shaped peaks buttressed the specificity of the method.
Conclusion: The proposed RP-HPLC method is simple, sensitive, rapid, cost-effective and accurate for the determination of APT in both bulk materials and pharmaceutical dosage forms.
Keywords: Aprepitant, RP-HPLC, Isocratic, Pharmaceutical dosage forms, Analysis, Validation
