HPLC法测定复方骨肽注射液中全蝎含量

HPLC determination of the scorpion in compound ossotide injection

目的:确定复方骨肽注射液中全蝎提取物成分的含量测定方法,区别骨肽注射液和复方骨肽注射液。方法:采用反相离子对高效液相色谱法,固定相:Lichrospher Phenyl 柱(4.6 mm×300 mm,5 μm),流动相:pH 4.5的醋酸-醋酸钠缓冲液(0.015 mol·L^(-1),含苄基三甲基氯化铵5 mmol·L^(-1)),紫外检测波长:240 nm,流速:1.0 mL·min^(-1),柱温:室温。结果:该色谱条件下得到骨肽与全蝎的指纹图谱,全蝎提取物浓度在2.5～10 mg·mL^(-1)范围内与峰面积呈良好线性关系(r=0.9984),最低检出限为0.4 mg·mL^(-1)(生药浓度),定量限为1.5 mg·mL^(-1)(生药浓度)。结论:该检测方法简便、快速、准确,稳定性良好,可用于对复方骨肽注射液的质量控制。

Objective：An HPLC method was established to detemine the extract of scorpion in compound ossotide injection and differentiate between compound ossotide injection and ossotide injection. Methods： An ion - pair RP - HPLC method was chosen. The Lichrospher Phenyl column（4. 6 mm ×300 mm,5 μm）was used. The mobile phase was HAc- NaAc buffer （0. 015 mol · L^-1 ,containing 5 mmol · L^-1 of benzyltrimethylammonium chloride） and adjusted to pH 4. 5 and the flow rate was 1.0 mL · min^- 1. The detection wavelength was 240 nm. The column temperature was room temperature （ approximate 25 ℃ ）. Results： The calibration curves were linear in the range of 2. 5 - 10 mg · mL^-1 for the extract scorpion （r =0. 9984）. The detection limit and quantitative limit of this method were 0. 4 mg·mL^- 1 and 1.5 mg· mL^- 1. Conclusion： The method is accurate and reliable for the quality control of compound ossotide injection.