Reverse Phase High Performance Liquid Chromatographic Method for Determination of Thymalfasin in Formulated Bulk Solution and Finished Dosage Form

Abstract

A simple, fast and sensitive reverse phase high performance liquid chromatographic method has been developed for the determination of thymalfasin by gradient elution in its dosage form. The separation of drug and al degradation products under various stress conditions was achieved using mixture of sodium phosphate buffer and acetonitrile at 1.0 mL/min flow rate on RP C₁₈ column. The detection was carried out at 210 nm. The method was statistically validated for its linearity, accuracy and precision. The intra- and inter-day variation was found to be less than 1% showing high precision of the assay method. The calibration curve was linear in the concentration range 50 to 150% of 400 ppm. Due to its specificity, high precision and accuracy, the proposed method may be used for determining Thymalfasin in formulated bulk solution or its finished dosage form.