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对已设计的吲达帕胺片剂处方进行筛选、工艺优化,并建立高效液相色谱法进行吲达帕胺片剂的有关物质检测。采用Hypersil ODS2(200mm×4.6mm,5μm)色谱柱,流动相为冰乙酸-乙腈-甲醇-0.2g/L EDTA二钠(0.1∶20∶20∶60,V/V/V/V),流速为1.0mL/min,检测波长为254nm,柱温为40℃。有关物质的检查方法完善了现版《中国药典》标准的色谱系统,更准确地进行杂质分析及限量,专属性强,可满足吲达帕胺片剂的有关物质测定。
The designed indapamide tablet prescription was screened, process optimization, and the establishment of high performance liquid chromatography indapamide tablets related substances detection. The mobile phase consisted of glacial acetic acid-acetonitrile-methanol-0.2 g / L disodium EDTA (0.1:20:20:60, V / V / V / V) using a Hypersil ODS2 column (200 mm × 4.6 mm, 5 μm) 1.0mL / min, the detection wavelength was 254nm, the column temperature was 40 ℃. The related substances inspection method has improved the chromatographic system of the current “Chinese Pharmacopoeia” standard, more accurate impurity analysis and limited, specific and strong, to meet the determination of indapamide tablets related substances.