盐酸二氧丙嗪片的含量、含量均匀度及溶出度测定方法研究  

Determination of Content,Content Uniformity and Dissolution Rate of Dioxypromazine Hydrochloride Tablets

作　　者：谭艳萍 朱清丽 涂蓉荣 李宁 朱远锋 TAN Yanping;ZHU Qingli;TU Rongrong;LI Ning;ZHU Yuanfeng(Ankang Food and Drug Testing Center,Ankang,Shaanxi,China 725000)

机构地区：[1]陕西省安康市食品药品检验检测中心,陕西安康725000

出　　处：《中国药业》2025年第7期73-76,共4页China Pharmaceuticals

摘　　要：目的完善盐酸二氧丙嗪片的质量标准。方法采用高效液相色谱法测定5个厂家样品的含量及含量均匀度,色谱柱为菲罗门Super Lu C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.2 mol/L醋酸铵溶液-三乙胺(45∶55∶0.3,V/V/V,用冰醋酸调p H至5.0),流速为1.0 mL/min,检测波长为264 nm,柱温为30℃,进样量为20μL。按2020年版《中国药典(四部)》附录0931溶出度与释放度测定法小杯法测定溶出度,以200 mL 0.1 mol/L盐酸溶液为溶出介质,转速为100 r/min,取样时间为30 min。结果盐酸二氧丙嗪的质量浓度在10~100μg/mL范围内与峰面积线性关系良好(r=0.9993,n=6);检测限为0.4438μg/m L,定量限为1.5287μg/mL;精密度、稳定性、重复性试验结果的RSD均小于1.0%;平均加样回收率为100.06%,RSD为0.75%(n=9)。5个厂家样品的平均标示量含量分别为97.71%,98.98%,100.02%,97.79%,99.01%(n=2),均在规定范围内。含量均匀度(A+2.2 S)分别为7.31,8.69,8.24,8.13,6.31,均一性符合标准(≤15)。平均溶出量分别为91.25%,96.56%,89.48%,95.23%,86.24%,均符合拟订限度(≥80%)。结论所建立的方法可靠易行,专属性、重复性均良好,灵敏度高,可更好地实现产品的质量控制,为厂家提升生产工艺水平提供参考。Objective To improve the quality standard of Dioxypromazine Hydrochloride Tablets.Methods High-performance liquid chromatography(HPLC)was used to determine the content and content uniformity of samples from five manufacturers,the chromatographic column was Phenomon SuperLu C18 column(250 mm×4.6 mm,5µm),the mobile phase was methanol-0.2%ammonium acetate solution-triethylamine(45∶55∶0.3,V/V/V,adjusted pH to 5.0 with glacial acetic acid),the flow rate was 1.0 mL/min,the detection wavelength was 264 nm,the column temperature was 30℃,and the injection volume was 20µL.According to the dissolution and release determination method(the small cup method)in appendix 0931 of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),the dissolution rate was determined,the dissolution medium was 200 mL of 0.1 mol/L hydrochloric acid solution,the rotation speed was 100 r/min and the sampling time was 30 min.Results The linear range of dioxpromazine hydrochloride was 10-100µg/mL(r=0.9993,n=6).The limit of detection was 0.4438µg/mL,and the limit of quantification was 1.5287µg/mL.The RSDs of precision,stability,and repeatability test results were all lower than 1.0%.The average recovery rate of dioxpromazine hydrochloride was 100.06%with an RSD of 0.75%(n=9).The average labeled contents of samples from five manufacturers were 97.71%,98.98%,100.02%,97.79%,99.01%(n=2),all within the specified range.The content uniformities(A+2.2 S)of samples from five manufacturers were 7.31,8.69,8.24,8.13,and 6.31,respectively,and all of which met the standard(≤15).The average dissolution rates of samples from five manufacturers were 91.25%,96.56%,89.48%,95.23%,and 86.24%,respectively,all of which met the proposed limits(≥80%).Conclusion The established method is reliable and feasible,with good specificity and repeatability,high sensitivity,which can better control product quality,and provide a reference for manufacturers to improve their production process level.

关 键 词：盐酸二氧丙嗪片 高效液相色谱法 含量测定 含量均匀度 溶出度 

分 类 号：R974.2[医药卫生—药品] R927.2[医药卫生—药学] R917