高效液相色谱法测定水合氯醛口服溶液含量

HPLC determination of chloral hydrate oral solution

目的:建立测定水合氯醛含量的高效液相色谱方法。方法:采用Shim-pack GIST C 18色谱柱(4.6 mm×250 mm,5μm),以乙腈-水(10∶90)为流动相,流速1.0 mL·min^(-1),检测波长210 nm,柱温35℃。结果:水合氯醛浓度在0.4011~1.604 mg·mL^(-1)范围内呈良好线性关系(r=0.9999);平均回收率为99.86%(RSD=0.18%,n=15)。方法检测限为6.07μg·mL^(-1),定量限为20.24μg·mL^(-1),供试品溶液在24 h内稳定性良好。结论:该方法可以用于水合氯醛的含量测定。

Objective:To establish an HPLC method for determination of chloral hydrate oral solution.Methods:The test was performed in a Shim-pack GIST C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of acetonitrile and water(10∶90).The flow rate was 1.0 mL·min^(-1),the column temperature was 35℃and the detection wavelength was 210 nm.Results:The linearity of chloral hydrate fell into 0.4011^(-1).604 mg·mL^(-1)(r=0.9999).The average recovery was 99.86%with RSD as 0.18%(n=15).The LOD was 6.07μg·mL^(-1) and the LOQ was 20.24μg·mL^(-1).The repeatability,precision and robustness met the requirements in ChP 2015.Conclusion:The established method can be used for determination of chloral hydrate.