高效液相色谱法测定鲑鱼降钙素鼻喷剂的含量

Content Determination of Salmon Calcitonin Nasal Sprays by HPLC

目的用高效液相色谱法(HPLC法)测定鲑鱼降钙素鼻喷剂的含量及有关物质。方法采用HypersilODS-C18柱(100mm×4.6mm,5μm),以pH=3.0的1mol/L氢氧化四甲基铵-水-乙腈(4∶346∶150)为流动相,紫外检测波长为210nm,流速为1.0mL/min,柱温为40℃,按外标法以峰面积计算含量。结果辅料和降解产物等对主药测定无干扰,鲑鱼降钙素浓度在3.0～30.0μg/mL范围内与峰面积线性关系良好,回归方程为Y=53043.65X-11917.89,r=0.9996,最低检出浓度为0.5μg/mL,平均回收率为99.81%(n=5)。结论HPLC法准确、可靠、重现性好,可用于鲑鱼降钙素鼻喷剂的含量及有关物质的测定。

Objective To establish HPLC method for the content determination of salmon ealcitonin nasal sprays and its related substances. Methods The chromatographic column was a Hypersil ODS-C18 column （100 mm ×4.6 mm,5 μm）. The mobile phase, 1 mol/L tetramethylammouium hydroxide - water - aeetouitrile（pH = 3.0） （4 ： 346 ： 150）,was used at a rate of 1. 0 mL/min. The detection wavelength was 210 nm and the extemal standard was adopted. Results Under the condition of test,the pharmaceutical aids and the decomposition products couht be well separated from salmon caleitonin. The linear range was 3.0- 30.0μg/mL and the linear regression equation was Y=53 043.65X- 11 917.89, r=0. 999 6. The lowest concentration of detection was 0.5μg/mL The average recoveries of preparation was 99.81% （n =5）. Conclusion The method developed is accurate, reliable and good reproducible. It is very suitable for the content determination of salmon calcitonin nasal sprays and its related substances.