Stability indicating RP-HPLC method development and validation for the determination of palonosetron in API and pharmaceutical dosage form

Abstract

A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been

developed for the determination of Palonosetron in bulk and pharmaceutical dosage form dosage form. The

chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5µm, 15cm x 4.6mm i.d.

column with UV detection at 254 nm and Methanol: Phosphate Buffer (0.05M) pH-3.8 with OPA (60:40) ratio

at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of

Palonosetron in bulk and pharmaceutical dosage form. The method was linear over the range of 6 -16µg/ml. The

recovery was in the range of 98% to 102% and limit of detection was found to be 0.006 µg/ml and

quantification was found to be 0.018 µg/ml. Different analytical performance parameters such as precision,

accuracy, limit of detection, limit of quantification and robustness were determined according to In ternational

Conference on Harmonization (ICH) guidelines.