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DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRY AND LIQUID CHROMATOGRAPHY METHODS FOR DETERMINATION OF CEFPIROME IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE

Authors

  • Tércio Paschke Oppe Universidade Federal do Rio Grande do Sul
    • Júlia Menegola
      • Elfrides Eva Scherman Schapoval

        DOI:

        https://doi.org/10.22456/2527-2616.93809

        Abstract

        In the present work, analytical methods, UV Spectrophotometry and Liquid Chromatography (HPLC), were developed and validated for quantification of cefpirome, a broad-spectrum fourth-generation cephalosporin, in raw material and powder for injectable preparation. The UV spectrophotometric method was performed at 271 nm, using 0.1 M hydrochloric acid as solvent. The HPLC was carried out using Techsphere ODS column and mobile phase consisted of methanol-water (30:70, v/v) with flow rate 0.8 mL/min and UV detection at 265 nm. The validation method yielded good results demonstrated statistically that the methods were linear, precise, accurate, specific and robust. A preliminary stability study of cefpirome showed that the UV Spectrophotometry and Liquid Chromatography methods were specific for the determination cefpirome in the presence of its degradation products. No statistically difference was observed between the proposed methods. The UV Spectrophotometry and Liquid Chromatography methods allow the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control.

         

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        Author Biography

        Tércio Paschke Oppe, Universidade Federal do Rio Grande do Sul

        3. Academic/ Educational background

        • Ph.D. in Pharmaceutical Sciences, Federal University of Rio Grande do Sul - UFRGS, Brazil. (Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul). Year of degree: 2007.
        • Master´s in Pharmaceutical Sciences, Federal University of Rio Grande do Sul - UFRGS, Brazil. (Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul). Year of degree: 1995.
        • Specialization in Production and Quality Control in the Medicine, Cosmetics and Food Industry, Federal University of Minas Gerais, UFMG, Brazil. Year of degree: 1990.
        • Graduation in Pharmacy, Federal University of Minas Gerais, UFMG, Brazil. Year of degree: 1989.

         

        2. Professional experience / Work experience / Positions held / Employment history

        • Federal University of Rio Grande do Sul – UFRGS, Professor and Researcher at the Faculty of Pharmacy in the area of Quality Control of Medicines, Medications and Cosmetics (physical, chemical and biological). 1997 – Current.
        • Federal University of Rio Grande do Sul – UFRGS, Pharmaceutical Equivalence Center (EQFAR20), Coordinator, Analyst and Researcher in Dissolution Test of Pharmaceutical Products for registration at Sanitary Surveillance Agency of Brazil (ANVISA). 2000 – 2014.
        • Federal University of Rio Grande do Sul – UFRGS, Laboratory of Pharmaceutical Quality Control (LCQFar), Laboratory Coordinator with the Network of Collaborating Laboratories of the Brazilian Pharmacopoeia - RELAF (ANVISA). 2010 – Current
        • Sanitary Surveillance Agency (ANVISA) - Brazilian Pharmacopoeia (Agência de Vigilância Sanitária). Research and Development of Monographs of Active Pharmaceutical Ingredients and Pharmaceutical Products. 1997 – Current. Sanitary Surveillance Agency (ANVISA) - Brazilian Pharmacopoeia (Agência de Vigilância Sanitária). Member of the Thematic Technical Committee of Active Pharmaceutical Ingredients (CTTIFA). 2009 – Current.
        • Sanitary Surveillance Agency (ANVISA) - Brazilian Pharmacopoeia (Agência de Vigilância Sanitária). Member of the Thematic Technical Committee of Raw Materials (CTT) of the Mercosul Pharmacopoeia. 2012 – 2017.
        • Lutheran University of Brazil – ULBRA (Universidade Luterana do Brasil), Professor at the Faculty of Pharmacy in the disciplines of Analytical Chemistry and Quality Control of Medicines, researcher in the area of quality control of drugs and medicines (physical, chemical and biological). 1993 – 1997.

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        Published

        17-07-2019

        Versions

        How to Cite

        Oppe, T. P., Menegola, J., & Schapoval, E. E. S. (2019). DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRY AND LIQUID CHROMATOGRAPHY METHODS FOR DETERMINATION OF CEFPIROME IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE. Drug Analytical Research, 3(1), 42–50. https://doi.org/10.22456/2527-2616.93809

        Issue

        Vol. 3 No. 1 (2019)

        Section

        ORIGINAL ARTICLES

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