HPLC separation and determination of three optical isomers of palonosetron hydrochloride.

To develop an HPLC method for separation and determination of three optical isomers in palonosetron hydrochloride. The analysis was carried out on CHIROBIOTIC TT (250 mm × 4.6 mm, 5 µm) chiral chromatography column with methanol-glacial acetic acid-triethylamine (100 : 0.5 : 0.3) as the mobile phase at the flow rate of 0.5 mL min–1, and the detection wavelength was 238 nm. Good retention and separation for palonosetron hydrochloride and its three optical isomers were achieved. The linear calibration was found for three optical isomers within the range of 2 to 20 µg mL–1 (r = 0.9992-0.9999). The precision was good with RSD of 0.88%-1.7% (n = 5). The developed method is specific and accurate with very good ruggedness and suitable for the determination of palonosetron hydrochloride and its three optical isomers.