Tsuji K, Goetz J F, Vanmeter W
J Pharm Sci. 1979 Sep;68(9):1075-80. doi: 10.1002/jps.2600680904.
The effect of 60Co-irradiation on penicillin G procaine in a peanut oil-based veterinary mastitis product was examined by reversed-phase high-performance liquid chromatography (HPLC). The HPLC method is capable of separating and quantifying procaine, penicillin G, and various degradation compounds. Penicillin G recovery from a placebo formulation was 100.4% with a relative standard deviation of less than 1%. When irradiated at 4.0 Mrads, the penicillin G in two product lots decreased slightly (approximately 1-2%) with a corresponding increase in two compounds inherently present in bulk penicillin G powder. These compounds may be formed in abundance by treating penicillin G in an acidic solution. From the mass spectrometric analysis and the relative retention data with authentic compounds, these compounds were identified as benzylpenilloaldehyde and benzylpenaldic acid. Values obtained by the HPLC method on the product irradiated and stored at various temperatures correlated well with those of the microbiological assay. No significant decrease in the procaine was detected even after 4.0-Mrad irradiation. The HPLC method is applicable for analysis of other beta-lactam antibiotics.
采用反相高效液相色谱法(HPLC)研究了60Co辐照对花生油基兽用乳腺炎产品中普鲁卡因青霉素G的影响。该HPLC方法能够分离和定量分析普鲁卡因、青霉素G以及各种降解产物。从安慰剂制剂中回收青霉素G的回收率为100.4%,相对标准偏差小于1%。当以4.0兆拉德的剂量进行辐照时,两个产品批次中的青霉素G略有下降(约1 - 2%),同时青霉素G原料药粉中固有存在的两种化合物相应增加。这些化合物可能通过在酸性溶液中处理青霉素G大量形成。通过质谱分析以及与标准化合物的相对保留数据,确定这些化合物为苄青霉素醛和苄青霉素酸。通过HPLC方法对在不同温度下辐照和储存的产品所获得的值与微生物测定法的值具有良好的相关性。即使在4.0兆拉德辐照后,也未检测到普鲁卡因有显著下降。该HPLC方法适用于分析其他β-内酰胺类抗生素。