Abstract
A simple and specific quantitative analysis method has been developed and validated for the determination of Argatroban Intermediate and its related substance. This method uses reversed-phase high performance liquid chromatography (RP-HPLC) to analyze the Argatroban Intermediate and its six related substance. Chromatographic conditions for RP-HPLC with UV detector were as follows: column, Agela Venusil MP, 250mm×4.6mm, 5μm; column temperature, 45°C; mobile phase, a 65: 35 (v/v) mixture of ammonium acetate buffer: methanol; flow rate, 1.0 mL/min. The detection wavelength was UV 272 nm. Under these conditions, excellent linearity was obtained (r2>0.9995) in the concentration range of 0.47~4.71μg/ml for Argatroban Intermediate, 0.30~5.04μg/ ml for impurity A, 0.12~4.93μg/ml for impurity B, 0.29~4.81μg/ ml for impurity C, 0.30~4.96μg/ml for impurity D,0.12~4.77μg/ ml for impurity E and 0.12~4.86μg/ml for impurity F, respectively. The LOQ was 0.5μg/ml for Argatroban Intermediate, 0.3μg/ml for impurity A, 0.125μg/ml for impurity B, 0.3μg/ml for impurity C,0.3μg/ml for impurity D, 0.125μg/ml for impurity E and 0.125μg/ ml for impurity F. The maximum R.S.D.(%) of the content of Argatroban Intermediate and its each impurity was 5.3% under the deliberate variations in method parameters.
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