RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY

SCOPUS
  • Year: 2021
  • Volume: 14
  • Issue: 3

Approved stability indicating reversed-phase-high performance liquid chromatographic assay method for Palonosetron HCl in formulations

Department of Chemistry, Bharath Institute of Higher Education and Research, Selaiyur, Chennai-600073, Tamilnadu, India.

Abstract

In the present paper a fundamental, affirmed dependability showing reverse phase RP-HPLC technique was imparted for palonosetron HCl in plan using Agilent C18 segment (250mm x 4.6mm I.D; atom size 5μm) with versatile stage comprising of acetonitrile and Buffer (pH-2.60±0.05) in the extent of 50: 50 (%v/v) at a stream pace of 1.0ml/min with UV discovery of 237nm in room temperature. Palonosetron HCl continuously eluted at the maintenance time 3.880min ordinarily. The regression examination revealed a straight calibration bend inside the centralization of 10–30μg/ml (r2=0.9993) for palonosetron HCl only. Truthful results of Student's t-test (0.46) for precision and F-test (2.25) for accuracy revealed no basic differentiation between the proposed RP-HPLC strategy and the announced technique at the 95% certainty level with respect to Exactness. As the approval results were inside the cutoff purposes of the International Conference on Harmonization rules (ICH) it is closed, that the made RP-HPLC test method can be used for standard quality control examination by pharmaceutical associations.

Keywords

RP-HPLC, International Conference on Harmonization guidelines (ICH)