Determination of related substances in carbazochrome sodium sulfonate injection by HPLC / 中国药学杂志

ABSTRACT

OBJECTIVE: To develop a method for separating and determining the related substances in carbazochrome sodium sulfonate injection. METHODS: HPLC Gradient elution was performed on an HP-ODS Hypersil colum. The mixture of 0.01 mol·L-1 phosphate buffer (pH 3.0) and acetonitrile (946) was used as mobile phase A, and acetonitrile as mobile phase B. The flow rate was 1.0 mL·min-1, the detection wavelength was set at 220 nm. RESULTS: After being treated with acid, base, heat and oxidation, carbazochrome sodium sulfonate underwent more or less degradation, the degradation products could be detected by the proposed method. Among the practical carbazochrome sodium sulfonate injection and carbazochrome sodium sulfonate and sodium choloride injection samples, the thermo degradation impurities but no impurities resulted from other treatments were detected in carbazochrome sodium sulfonate injections and carbazochrome sodium sulfonate sodium chloride injections. CONCLUSION: The proposed method can be used to separate and determine the related substances in carbazochrome sodium sulfonate injection, and is suitable for the quality control of this drug.