Tsuji K, Kane M P
J Pharm Sci. 1982 Oct;71(10):1160-4. doi: 10.1002/jps.2600711021.
A stability-indicating high-pressure liquid chromatographic (HPLC) method for the assay of erythromycin in enteric film-coated tablets was developed. The method used a reversed-phase column at 70 degrees with a mobile phase of acetonitrile-methanol-0.2 M ammonium acetate-water (45:10:10:35) at pH 7.0. The column were evaluated for the analysis of erythromycin. The HPLC method was also applicable for the analysis of salts and esters of erythromycin. The linearity and precision of the HPLC assay method for erythromycin in the solid dosage form were examined by spiking erythromycin into a tablet placebo a 60-120% of the label. The recovery of erythromycin was 99.9% with a relative standard deviation of less than 1%. The correction factors to express the results of HPLC in terms of antimicrobial bioequivalency against Staphylococcus aureus TCC 6538P for erythromycins A, B, and C were determined to be 1.0, 0.92, and 0.48, respectively. Eight lots of tablets were assayed by the HPLC method, and the results, expressed in terms of erythromycin bioequivalency, showed no statistically significant difference from those of the microbiological assay method.
建立了一种用于测定肠溶包衣片中红霉素的稳定性指示高压液相色谱（HPLC）方法。该方法在70℃下使用反相柱，流动相为乙腈 - 甲醇 - 0.2M醋酸铵 - 水（45:10:10:35），pH值为7.0。对该色谱柱进行了红霉素分析评估。该HPLC方法也适用于红霉素盐和酯的分析。通过将红霉素以标示量的60 - 120%加入片剂安慰剂中，考察了该HPLC测定法对固体剂型中红霉素的线性和精密度。红霉素的回收率为99.9%，相对标准偏差小于1%。确定以对金黄色葡萄球菌TCC 6538P的抗菌生物等效性表示HPLC结果时，红霉素A、B和C的校正因子分别为1.0、0.92和0.48。采用HPLC方法对8批片剂进行了测定，以红霉素生物等效性表示的结果与微生物测定法的结果相比，无统计学显著差异。
