Accurate, rapid and selective reversed phase ultra-performance liquid chromatography method with UV detection has been established and validated for the synchronous determination of aceclofenac (ACE) and diacerin (DIA) in the occurrence of diclofenac sodium and rhein, their main degradation products, respectively. Chromatographic separation was accomplished using Inertsil C-18 column (50 × 2.1 mm i.d., 1.7 μm particle size) in isocratic mode, with mobile phase consisting of 20 mM ammonium acetate buffer:acetonitrile in the ratio of 42:58 (v/v), pH adjusted to 3.00 by using 10% acetic acid, the flow rate of 0.25 mL/min and UV detection was performed at 265 nm. The retention times were 2.00 +/− 0.24, 2.69 +/− 0.19, 4.00 +/− 0.23 and 5.24 +/− 0.25 min for DIA, rhein, ACE and diclofenac sodium, respectively. Excellent linearity was shown over a range of 1.0–150.0 μg/mL and 0.5–87.5 μg/mL with mean percentage recoveries of 98.87 ± 1.19 and 98.84 ± 1.08 for ACE and DIA, respectively. Parameters of precision and accuracy of the method meet the established criteria. The obtained RSD values were quite low and indicate good reproducibility of the method. Thus, the developed method can be used for the combined dosage form analysis and its chemical stability studies.

中文翻译：

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醋氯芬酸和Diacerin粉末形式和基质制剂的同步UPLC拆分：稳定性研究。

建立了准确，快速，选择性的带紫外检测的反相超高效液相色谱方法，并已验证其在主要降解产物双氯芬酸钠和大黄酸分别发生时同时测定醋氯芬酸（ACE）和双醋精（DIA）的有效性。 。色谱分离使用Inertsil C-18色谱柱（内径50×2.1 mm，粒径1.7μm）在等度模式下完成，流动相由20 mM乙酸铵缓冲液：乙腈组成，比率为42:58（v / v）用10％乙酸将pH调至3.00，流速为0.25mL / min，并在265nm处进行UV检测。对于DIA，大黄酸，ACE和双氯芬酸钠，保留时间分别为2.00 +/- 0.24、2.69 +/- 0.19、4.00 +/- 0.23和5.24 +/- 0.25min。在1.0–150.0μg/ mL和0.5–87.5μg/ mL的范围内显示出极好的线性，ACE和DIA的平均回收率分别为98.87±1.19和98.84±1.08。该方法的精密度和准确性参数符合既定标准。获得的RSD值非常低，表明该方法具有良好的重现性。因此，所开发的方法可用于组合剂型分析及其化学稳定性研究。