The Estimation of Palonosetron Hydrochloride in Parenterals by RP-HPLC.

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Palonosetron Hydrochloride in dosage form. An XTerra(R) C18 analytical column (250x4.6 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 Orthophosphoric acid and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 242 nm. The retention time was 10.9 min. The detector response was linear in the concentration of 5–30 mcg/mL. The respective linear regression equation being y= 3644.3x-3644.7. The limit of detection and limit of quantification was 2.5ng/mL and 7.5ng/mL respectively. The percentage assay of Palonosetron Hydrochloride 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 Palonosetron Hydrochloride in bulk drug and in its pharmaceutical parenterals form.