HPLC法测定硝酸毛果芸香碱注射液的含量与有关物质

Determination of Pilocarpine Nitrate Injection and Its Related Substances by HPLC

目的:建立高效液相色谱法测定硝酸毛果芸香碱注射液的含量及有关物质。方法:采用C18柱,流动相为甲醇-含0.002mol.L-1磷酸二氢铵和0.0018 mol.L-1四丁基氢氧化铵的水溶液(30∶70),检测波长220 nm。用外标法测定含量,不加校正因子的自身对照法测定有关物质。结果:有关物质浓度在0.510～153.1μg.mL-1,含量测定浓度在51.58～515.8μg.mL-1范围内与峰面积呈良好的线性关系。硝酸毛果芸香碱主成分峰与有关物质峰的分离度均符合要求,硝酸毛果芸香碱的检出限为4 ng。结论:本方法简便、准确,灵敏度高,适用于该制剂的含量及有关物质测定。

Objective： To establish an HPLC method for determination of the content and related substances of Pilocarpine Nitrate In- jection. Methods： A Shimadzu CIs column （4. 6 mm×150 ram,5 μm） was used. The mobile phase consistiing of methanol-water so- lution Including 0. 002 mol · L-I ammonium dihydrogen phosphate and 0. 0018 mol ·L-1 tetrabutyl ammonium hydroxide （30： 70）. The detection wavelength was 220 nm. Results： The linear ranges were 0. 510-153.1 μg · mL-l （ r = O. 999 9） for the related sub- stances and 51.58-515.8 μg · mL- 1 （r = 0. 999 8 ） for the pilocarpine nitrate. The separation between pilocarpine nitrate and other im- purities was satisfactory. The detection limit for piloearpine nitrate was 4 ng. Conclusion：The method is simple, accurate and sensi- tive. It can be used for the determination of PiLocarpine Nitrate Injection and Its related substances.