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建立了复方L-18甲基炔诺酮(LNG)长效注射剂中LNG的反相高效液相色谱(RP-HPLC)测定法。采用YWG-C_(18)H_(37)(10μm)柱(150×5mm ΙD),甲醇-水(75:25)流动相,固定波长UV 254 nm检测器,以醋酸可的松为内标。色谱进样前须将注射液用甲醇稀释,并离心除去所析出的甲醇不溶性辅料。本法线性良好(r=0.9999),同次测定平均回收率为99.50±0.59％(n=21),不同次测定为99.94±0·86％(n=15),该混悬注射剂中另一主药雌二醇及各辅料均无干扰。应用本法测定了样品注射液5个批号,结果符合要求。
A reverse phase high performance liquid chromatography (RP-HPLC) method for the determination of LNG in compound L-18 methyl norethindrone (LNG) long-acting injection was established. The mobile phase consisted of YWG-C 18 H 37 column (150 × 5mm ΙD), methanol-water (75:25) and fixed wavelength UV 254 nm detector with cortisone acetate as internal standard. The chromatographic injection should be diluted with methanol and centrifuged to remove the precipitated methanol-insoluble excipients. The method was linear (r = 0.9999). The average recovery was 99.50 ± 0.59% (n = 21) for the same assay and 99.94 ± 0.86% (n = 15) for different times. The other of the suspension injections The main drug estradiol and the accessories were not disturbing. This method was applied to determine the sample injection five batches, the results meet the requirements.