摘要
Abstract
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,5 µm),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 20 µL.According to the dissolution and release determination method(the small cup method)in appendix 0931 of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),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 10-100 µg/mL(r=0.999 3,n=6).The limit of detection was 0.443 8 µg/mL,and the limit of quantification was 1.528 7 µg/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Key words
Dioxypromazine Hydrochloride Tablets/HPLC/content determination/content uniformity/dissolution rate分类
医药卫生
