HPLC法测定复方盐酸阿替卡因注射液肾上腺素及磺酸肾上腺素含量的分析方法

Determination of Epinephrine and Epinephrine Sulfonate in Compound Articaine Hydrochloride Injection by HPLC

目的:建立HPLC法测定复方盐酸阿替卡因注射液磺酸肾上腺素和肾上腺素的含量,并验证该方法的适用性。方法:采用高效液相色谱法测定。色谱柱:用十八烷基键合硅胶为填充剂;以1.1%庚烷磺酸钠溶液(用1mol/L磷酸溶液调节pH值至2.5)为流动相A,乙腈为流动相B,进行梯度洗脱;采用荧光检测器,激发波长为280 nm,发射波长为320 nm;流速为0.8 mL/min;柱温和实验室温度均为25 ℃±2 ℃,进样量为20 μL。结果:本方法系统适用性良好,磺酸肾上腺素在0.01~1.00 μg/mL(线性浓度:定量限浓度~200%)范围内线性关系良好,肾上腺素在2.5~10.0 μg/mL(线性浓度:50%~200%)范围内线性关系良好;准确度、精密度和溶液稳定性都符合要求。结论:本分析方法符合方法学验证的要求,可以满足检测要求。

Objective:An HPLC method was established to determine the content of epinephrine sulfonate and epinephrine in compound articaine hydrochloride injection,and the applicability of the method was verified.Method:Measured by high performance liquid chromatography.Chromatographic column:use octadecyl-bonded silica gel as a filler;use 1.1%sodium heptane sulfonate solution(adjust the pH to 2.5 with 1 mol/L phosphoric acid solution)as mobile phase A and acetonitrile as mobile phase B for gradient Elution:Fluorescence detector is used,excitation wavelength is 280 nm,emission wavelength is 320 nm;flow rate is 0.8 mL/min;column temperature and laboratory temperature are both 25℃±2℃,sample volume is 20μL.Results:This method has a good system applicability.Epinephrine sulfonate has a good linear relationship within the range of 0.01~1.00μg/mL(linear concentration:the limit of quantification~200%),and epinephrine is within 2.5~10.0μg/mL(linear concentration:50%~200%),the linear relationship is good;accuracy,precision and solution stability meet the requirements.Conclusion:This analysis method meets the requirements of methodological verification and can meet the testing requirements.