Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PALONOSETRON HYDROCHLORIDE IN ITS PARENTERAL DOSAGE FORM

Miss Dhruvika Parekh*, Dr. Chirag J. Patel and Dr. M. M. Patel

Abstract

A selective and simple stability indicating reversed phase HPLC method using Naphthalethyl stationary phase C18 column (250 x 4.6mm, 5μm) was developed and validated for the quantitative determination of Palonosetron Hydrochloride in its Parenteral dosage form. Chromatographic separation (Rs > 2) was achieved with Isocratic mode-Mobile Phase: Solution-A: Solution-B (35:65) (Solution A-Buffer (Potassium dihydrogen Phosphate, Triethylamine pH 2.5), & Solution B-Buffer: ACN (50:50) of elution at a flow rate of 1 mL/min and with UV detection at 210 nm. Retention time of Palonosetron hydrochloride was found to be 7 min. This drug was subjected to Hydrolysis, oxidation, Photolysis and thermal to apply stress conditions. Linearity for Palonosetron hydrochloride was found In the Range of 28.06- 84.19 microgram/milliliter (R2 = 0.999). The accuracy of the present method was evaluated at 50%, 100% and 150%. The % recoveries of Palonosetron hydrochloride was found to be in the range of 99–101%. Precision studies were carried out and the relative standard deviation (RSD) values were less than 2.

Keywords: Palonosetron Hydrochloride, Parenteral dosage form, Stability Studies, HPLC, Forced Degradation.