高效液相色谱法测定儿科用药盐酸异丙嗪片的含量均匀度及分剂量研究  

Determination of content uniformity and dosage distribution of isopromazine hydrochloride tablets in pediatric medicine by high performance liquid chromatography

作　　者：赵雪娜 孙晶 ZHAO Xue-Na;SUN Jing(Jinchang Drug Inspection and Testing Center,Jinchang 737100,China;Jinchang Central Hospital,Jinchang 737100,China)

机构地区：[1]金昌市药品检验检测中心,金昌737100 [2]金昌市中心医院,金昌737100

出　　处：《实验室检测》2024年第8期99-103,共5页Laboratory Testing

摘　　要：目的 建立高效液相色谱法测定盐酸异丙嗪的含量均匀度,为后续研究儿科用药手工掰片后的含量均匀度和含量的质量提供可靠实验依据。方法 采用高效液相色谱法,用十八烷基硅烷键合硅胶为填充剂的色谱柱,水(用冰醋酸调节p H值至2.3)-甲醇(55∶45)为流动相,检测波长为254 nm。结果 盐酸异丙嗪在17.392~26.088μg/m L范围内呈良好的线性关系,线性方程为:Y=55272X+348938(r^(2)=0.9986),方法回收率在100.22%~101.40%之间,RSD为0.49%,盐酸异丙嗪含量均匀度测定结果符合《中国药典》2020年版四部通则的规定。最后用此方法通过盐酸异丙嗪片的含量及含量均匀度对不同方法分剂量使用对儿童用药的准确性做相应分析。结论 该方法测定盐酸异丙嗪含量均匀度和含量的专属性强,准确度和精密度均良好;儿童用药片分剂量使用的剂量准确性随分剂量次数的增加而降低。此研究为推动儿童用片剂药的剂量准确性提供了非常重要的数据理论和实际意义。Objective To establish a high performance liquid chromatography method for the determination of the content uniformity of promethazine hydrochloride,and to provide a reliable experimental basis for the subsequent study of the content uniformity and content quality of pediatric drugs after manual breaking tablets.Methods High performance liquid chromatography was used,octadecyl silane bonded silica gel was used as the column filling agent,water(adjusted pH to 2.3 with glacial acetic acid)-methanol(55∶45)was used as the mobile phase,and the detection wavelength was 254 nm.Results Promethazine hydrochloride showed a good linear relationship in the range of 17.392~26.088μg/mL,and the linear equation was:Y=55272X+348938(r^(2)=0.9986).The method recovery rate was between 100.22%and 101.40%,and the RSD was 0.49%.The content uniformity of promethazine hydrochloride was in accordance with the provisions of the four general principles of the Chinese Pharmacopoeia 2020 edition.Finally,this method was used to analyze the accuracy of children’s drugs by different methods of dosing by the content and content uniformity of promethazine hydrochloride tablets.Conclusion The method has strong specificity in determining the content uniformity and content of promethazine hydrochloride,and the accuracy and precision are good.The dose accuracy of children’s tablets is reduced by many times of dosing,and it also provides very important data theoretical and practical significance for promoting the dose accuracy of children’s tablets.

关 键 词：高效液相色谱法 盐酸异丙嗪 含量均匀度 药片分剂量 准确性 儿童用药 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]