Determination of the purity of ampicillin by micellar electrokinetic chromatography and reversed phase liquid chromatography on a monolithic silica column

Journal of Separation Science
Milada DolelalováRoman Jobánek

Abstract

A micellar electrokinetic chromatographic (MEKC) method and a fast reversed-phase liquid chromatographic one have been developed for determining the purity of ampicillin. MEKC separation of ampicillin and its related substances was performed with the use of an untreated fused-silica capillary and 40 mM phosphate-borate buffer, pH 7.5 containing 75 mM SDS. The HPLC method employed a monolithic silica C18 column and a mobile phase composed of phosphate buffer, pH 5.2 and ACN, the flow rate being 4.0 mL/min. Both methods were successfully validated. Linearity, relative response factors, limits of quantitation, intermediate precision, and accuracy were evaluated. The methods proved to be fast, reliable, and sufficiently sensitive and, accordingly, well-suited for control of purity of ampicillin substance, injections, and capsules. A combination of both methods can be very useful in the confirmation of impurity profiles.

Citations

Jan 10, 2008·AAPS PharmSciTech·Alireza GhassempourMohammad Erfan
Feb 17, 2005·Electrophoresis·Theron J PappasLisa A Holland
Jan 20, 2006·Electrophoresis·Carmen García-Ruiz, María Luisa Marina

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