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Development of HPLC method for the determination of levosulpiride in human plasma.

Journal of pharmaceutical and biomedical analysis (2004-06-15)
Su-Eon Jin, Eunmi Ban, Yang-Bae Kim, Chong-Kook Kim
ABSTRACT

A rapid and simple high performance liquid chromatography (HPLC) method was developed and validated for determination of levosulpiride in human plasma. After extraction with ethylacetate/methylene chloride (5:1, v/v), analysis of levosulpiride in plasma samples was carried out using a reverse phase C18 column with fluorescence detector (maximum excitation at 300 nm and maximum emission at 365 nm) for separation and quantification. A mixture of methanol-20 mM phosphate buffer (pH 3.5, 16:84, v/v) was used as a mobile phase. The method was specific and sensitive with a limit of quantification of 5 ng/ml. This HPLC method was validated by examining the precision and accuracy for inter- and intra-day analysis in the concentration range of 5-150 ng/ml. The relative standard deviation (R.S.D.) in inter- and intra-day validation were 8.16-19.75 and 3.90-11.69%, respectively. In stability tests, levosulpiride in human plasma was stable during the storage and assay procedure. The method was applied to the bioequivalence study of two levosulpiride tablet formulations (25 mg) after a single oral administration.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
(S)-(−)-Sulpiride, ≥98% (titration)
Supelco
(S)-(−)-Sulpiride, VETRANAL®, analytical standard
Supelco
Butyric acid, analytical standard
Sigma-Aldrich
Butyric acid, ≥99%
Sigma-Aldrich
Butyric acid, natural, ≥99%, FCC, FG
Sigma-Aldrich
Butyric acid, ≥99%, FG