[Determination of R(-)- isomer in repaglinide tablets by capillary electrophoresis].

ABSTRACT

OBJECTIVE: To develop a capillary electrophoresis system for enantiomeric impurity test of repaglinide. METHODS: An uncoated fused silica capillary (50 µm×50 cm, with an effective length of 41 cm) was used. The running buffer was composed of 30 mmol/L NaH2PO4 and 5 mg/ml carboxymethyl-ß-cyclodextrin(pH 3.5). RESULTS: Linear range was 2.00-80.00 µg/ml (correlation coefficient was 0.9993). The average recovery rate was 92.5% to 105.0%. CONCLUSION: The method is simple, accurate and sensitive and it can be used for determination of enantiomeric impurities in repaglinide tablet.