Wallo W E, D'Adamo A
J Pharm Sci. 1982 Oct;71(10):1115-8. doi: 10.1002/jps.2600711009.
A reversed-phase pressurized liquid chromatographic procedure is presented for the simultaneous quantitation of hydrocodone bitartrate and acetaminophen in a tablet formulation. The separation method was based on an octadecylsilane column with a buffered (pH 4.5) methanol-water mobile phase. Measurement was with a UV spectrophotometer set at 283 nm, compared to external standards. Assays for the active ingredients in tablet samples averaged 99.7% of the label claim for hydrocodone bitartrate and 100.3% for acetaminophen. The respective relative standard deviations of the retention time and precision were 2.2 and 1.75% for hydrocodone and 3.3 and 0.95% for acetaminophen. The range of interest studied was 0.035 to 0.065 mg/ml for hydrocodone bitartrate and 3.50 to 6.50 mg/ml for acetaminophen. The assay method was also compared to colorimetric and USP procedures for the active ingredients. The method was suitable for control, content uniformity, and stability-indicating use.
本文介绍了一种反相加压液相色谱法，用于同时定量片剂制剂中的酒石酸氢可酮和对乙酰氨基酚。该分离方法基于十八烷基硅烷柱，采用缓冲（pH 4.5）甲醇-水流动相。与外标相比，使用设定在283 nm的紫外分光光度计进行测量。片剂样品中活性成分的测定结果平均为酒石酸氢可酮标签标示量的99.7%，对乙酰氨基酚为100.3%。酒石酸氢可酮保留时间和精密度的相对标准偏差分别为2.2%和1.75%，对乙酰氨基酚分别为3.3%和0.95%。所研究的感兴趣范围为酒石酸氢可酮0.035至0.065 mg/ml，对乙酰氨基酚3.50至6.50 mg/ml。该测定方法还与活性成分的比色法和美国药典方法进行了比较。该方法适用于对照、含量均匀度和稳定性指示用途。
