反相高效液相色谱法测定盐酸格拉司琼葡萄糖注射液的含量及有关物质

Determination of granisetron hydrochloride and related substances in granisetron hydrochloride and glucose injection by reverse phase high-performance liquid chromatography

目的建立盐酸格拉司琼葡萄糖注射液含量及有关物质的反相高效液相色谱（RP—HPLC）测定法。方法采用C18色谱柱，磷酸盐缓冲液（pH值2．0）（取无水磷酸二氢钠15．6g溶解于900ml水中，用磷酸调节pH值至2．0，加水稀释至1000ml）-甲醇-四氢呋喃（75：24：1．1）为流动相，流速1．2m]／min，检测波长300nm。结果盐酸格拉司琼与杂质A、B、C、D及5-羟甲基糠醛的分离度均符合要求，系统适用性良好，盐酸格拉司琼在0．4426—2．213txg范围内线性关系良好，方法平均回收率为100．1％（相对标准偏差=0．26％）。结论该法简便、准确，可用于盐酸格拉司琼葡萄糖注射液的主药含量及有关物质测定。

Objective To establish a reverse phase high-performance liquid chromatography （RP-HPLC） method for determination of granisetron hydrochloride and related substances in granisetron hydrochloridc and glucose injection. Methods A eclipse XDB-C18 column was used with mobile phase of phosphate buffer （ pH 2.0） （ measure sodium dihydrogen phosphate anhydride 15.6g dissolved in water of 900 ml, then regulated pH to 2.0 with phosphoric acid and diluted to 1000 ml with water）-methanol-tetrahydrofuran（75： 24：1.1 ）. The flow rate was 1.2 ml/ rain and the detection wavelength was 300 nm. Results There was a good resolution between the granisetron hydrochloride and all the impurities（A, B, C, D） as well as the 5-HMF, and the system suitability was fine. It had a good linearity over the concertration range of 0. 4426-2. 213 μg. The average recovery was 100. 1% with RSD of 0. 26%. Conclusions The method is accurate and convenient. It can be used for determination of granisetron hydrochloride and related substances in granisetron hydrochloride and glucose injection.