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Arzneimittelforschung 2008; 58(2): 91-96
DOI: 10.1055/s-0031-1296474
Antibiotics · Antimycotics · Antiviral Drugs · Chemotherapeutics · Cytostatics
Editio Cantor Verlag Aulendorf (Germany)

Determination of Ampicillin in Human Plasma by Solid-phase Extraction – Liquid Chromatography – Tandem Mass Spectrometry (SPE-LC-MS/MS) and its Use in Bioequivalence Studies

Talita Mota Gonçalves
1   NUDFAC–Núcleo de Desenvolvimento Farmacêutico e Cosmético – NUDFAC-UFPE, Centro de Biodisponibilidade / Bioequivalência, Departamento de Ciências Farmacêuticas, Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil
,
Danilo César Galindo Bedor
1   NUDFAC–Núcleo de Desenvolvimento Farmacêutico e Cosmético – NUDFAC-UFPE, Centro de Biodisponibilidade / Bioequivalência, Departamento de Ciências Farmacêuticas, Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil
,
Luís Renato Pires de Abreu
1   NUDFAC–Núcleo de Desenvolvimento Farmacêutico e Cosmético – NUDFAC-UFPE, Centro de Biodisponibilidade / Bioequivalência, Departamento de Ciências Farmacêuticas, Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil
,
Carlos Eduardo Miranda de Sousa
1   NUDFAC–Núcleo de Desenvolvimento Farmacêutico e Cosmético – NUDFAC-UFPE, Centro de Biodisponibilidade / Bioequivalência, Departamento de Ciências Farmacêuticas, Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil
,
Clarice M Bueno Rolim
2   CEBIFAR–Centro de Estudos de Bioequivalência e Farmacocinética, Departamento de Farmácia Industrial, Universidade Federal de Santa Maria, Rio Grande do Sul, Brazil
,
Davi Pereira de Santana
1   NUDFAC–Núcleo de Desenvolvimento Farmacêutico e Cosmético – NUDFAC-UFPE, Centro de Biodisponibilidade / Bioequivalência, Departamento de Ciências Farmacêuticas, Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil
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Further Information

Publication History

Publication Date:
15 December 2011 (online)

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Abstract

A simple, fast, sensitive and selective solid-phase extraction-liquid chromatography-tandem mass spectrometry (SPE-LC-MS/MS) method for the quantitative analysis of ampicillin (CAS 69-53-4) in human plasma was developed using amoxicillin as internal standard, and sample extraction by solid-phase extraction (SPE). Extracts were separated by reversed-phase C18 with aqueous mobile phase (acetonitrile, 80:20, v/v) with 0.1% formic acid. The method was validated and successfully applied in a bioequivalence study of capsules 500 mg of ampicillin. Using a short running time of 2.5 min, the lower limit of quantification (LLOQ) for obtained ampicillin was 0.1 µg/ml for a plasma sample of 250 µl and a recovery of 94.38% ± 4.05. Bioequivalence between the products was determined by calculating 90% confidence intervals (CI) for the ratio of Cmax, AUC0–t and AUC0–inf values for the test and reference products, which were within the 0.80–1.25 interval proposed by FDA and EMEA. It is concluded that the two formulations are bioequivalent in their rate and extent of absorption, and thus, may be used interchangeably.

Key words

Ampicillin, bioequivalence, tandem mass spectrometry - Antibiotics - CAS 69-53-4
 

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