A simple isocratic RP-HPLC method for quality control of oseltamivir capsules

Authors

  • Agim Ameti Institute for Public Health of the Republic of Macedonia
  • Jasmina Slavkovska Institute for Public Health of the Republic of Macedonia
  • Katerina Starkoska Institute for Public Health of the Republic of Macedonia
  • Zorica Arsova-Sarafinovska Institute for Public Health of the Republic of Macedonia

DOI:

https://doi.org/10.20450/mjcce.2012.10

Keywords:

Oseltamivir, RP-HPLC, HPLC-DAD, Quality control, Pharmaceuticals

Abstract

A simple isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed for determination of oseltamivir active pharmaceutical ingredient (API) in bulk drug and pharmaceuticals. The separation was achieved on a Purospher STAR® RP – 18e column with a mobile phase consisting of methanol- 0.02 mol l-1 phosphate buffer, pH 5, 50:50 (v/v). Chromatographic results demonstrated the specificity of the method for determination of oseltamivir in presence of degradation products generated in studies of forced decomposition. The limit of detection (LOD) and limit of quantification (LOQ) for oseltamivir phosphate were 0,0162 μg ml-1 and 0,0491 μg ml-1, respectively. The advantages of this method include simple sample treatment and short elution time (less than 6 min). Furthermore, using methanol instead of acetonitrile in a mobile phase composition considerably reduces the laboratory expenses, still retaining adequate sensitivity for routine analysis as well as for evaluation of potentially counterfeit Tamiflu® products.

 

Author Biographies

Agim Ameti, Institute for Public Health of the Republic of Macedonia

Analyst, Chemical - Pharmaceutical Section, Department for Quality Control of Medicines, Institute of Public Health, Skopje, Republic of Macedonia

Jasmina Slavkovska, Institute for Public Health of the Republic of Macedonia

Analyst, Chemical - Pharmaceutical Section, Department for Quality Control of Medicines, Institute of Public Health, Skopje, Republic of Macedonia

Katerina Starkoska, Institute for Public Health of the Republic of Macedonia

Head of the Department for Quality Control of Medicines, Institute of Public Health, Skopje, Republic of Macedonia

Zorica Arsova-Sarafinovska, Institute for Public Health of the Republic of Macedonia

Head of the Chemical - Pharmaceutical Section, Department for Quality Control of Medicines, Institute of Public Health, Skopje, Republic of Macedonia

Head of the Laboratory Reference Centre, Institute of Public Health, Skopje, Republic of Macedonia

Assistant Professor, Faculty of Medicine, “Goce Delcev” University, Stip, Republic of Macedonia

Technical Assessor, Expert for ISO/IEC 17025, Sector for accreditation of testing laboratories, Institute of Accreditation of the Republic of Macedonia

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Published

2012-12-20

How to Cite

Ameti, A., Slavkovska, J., Starkoska, K., & Arsova-Sarafinovska, Z. (2012). A simple isocratic RP-HPLC method for quality control of oseltamivir capsules. Macedonian Journal of Chemistry and Chemical Engineering, 31(2), 205–215. https://doi.org/10.20450/mjcce.2012.10

Issue

Section

Analytical Chemistry

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