QUANTITATIVE DETERMINATION OF RESIDUAL SOLVENTS IN PALONOSETRON API BY HS-GC METHOD

Authors

  • SUNNY GRACE GODE Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, Telengana State. https://orcid.org/0000-0002-1289-6612
  • VIJAYA LAKSHMI GOLLAPALLI Department of Chemistry, Osmania University College for Women, Koti, Hyderabad, Telangana, India.

DOI:

https://doi.org/10.22159/ajpcr.2022.v15i2.43669

Keywords:

Palonosetron, Residual solvents, Headspace gas chromatography, International conference on harmonization

Abstract

Objectives: Palonosetron is an antidote to 5-HT3 in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). The presence of residual solvents in pharmaceutical drug substances or products, as well as excipients, can have a detrimental effect on the product’s quality and stability. These substances must be evaluated for safety and efficacy. The primary purpose of this work is to establish a method for validating and quantifying residual solvents in palonosetron API using Head Space Gas Chromatography (HS-GC).

Methods: In the proposed HS-GC technique for the quantifying residual solvents - ethanol, acetone, methanol, acetonitrile, and isopropyl alcohol (IPA) in Palonosetron API, the headspace equilibrium was achieved at 100°C and analyzed by DB-624 column (30 m × 0.24 mm, 1.8 μm) with injector and detector temperature set at 200°C and 230°C respectively. The dissolving solvent was dimethyl sulfoxide (DMSO). After the initial holding time of 5mins, the temperature was increased to 120°C from 40°C in 20mins at a rate of 10°C/min using a flow rate of 10 ml/min and a split ratio of 1:25 with nitrogen as carrier gas. The approach created has been validated and quantified as per International Conference on Harmonization’s (ICH) guidelines.

Results: All the results obtained were within the ICH specified limits. The validation results for repeatability studies (%RSD values) were found to be <10; recovery studies values were in the range of 90–110% and for the selected linearity range 25–150 μg/ml the correlation coefficients(γ2) for all the solvents were observed to be >0.99.

Conclusion: A sensitive, simple, precise, and economic HS-GC method with Flame Ionization Detector (FID) was developed and validated to quantitatively determine the residual solvents in Palonosetron API.

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Published

07-02-2022

How to Cite

GODE, S. G., and V. L. GOLLAPALLI. “QUANTITATIVE DETERMINATION OF RESIDUAL SOLVENTS IN PALONOSETRON API BY HS-GC METHOD”. Asian Journal of Pharmaceutical and Clinical Research, vol. 15, no. 2, Feb. 2022, pp. 75-81, doi:10.22159/ajpcr.2022.v15i2.43669.

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