Estimation of Atosiban Acetate in Parenterals by Rp HPLC

Abstract

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Atosiban Acetate in dosage form. An XTerra MS C18 analytical column (250 x 4.6 mm, 5 μm partical size) with mobile phase consisting of mixture of buffer 0.03M Potassium Dihydrogen Orthophosphate in water and pH adjusted to 3.20 with ortho-phosphoric acid and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 220 nm. The retention time was 11.3 min. The detector response was linear in the concentration of 15-225 mcg/mL. The respective linear regression equation being y = 1286.9 x-1290.8. The limit of detection (LOD) and limit of quantification (LOQ) for Atosiban Acetate were found to be 1.5 mcg/mL and 4.5 mcg/mL respectively. The percentage assay of Atosiban Acetate was 99.6 %. The method was validated by determining its accuracy, precision and linearity. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Atosiban Acetate in bulk drug and in its pharmaceutical parenterals.