A comparative study of two separate analytical techniques for the simultaneous determination of diclofenac sodium and diacerein from combined dosage form

ABSTRACT Diclofenac sodium (DS) and diacerein (DC) have emerged as a potential combination therapy for the treatment of knee osteoarthritis. Therefore a validated analytical method is essential for the simultaneous estimation of both from combined dosage form. A ratio derivative spectrophotometric and a chromatographic technique have been developed for the simultaneous determination of DS and DC. The quantification was done at 263.00 nm for DC and 304.50 nm for DS in the first method, whereas 257 nm for DC and at 274 nm for DS for LC-DAD analysis in chromatographic method using acetate buffer and methanol as the mobile phase at a flow-rate 0.50 mL/min. Both of these methods are found to be linear in the concentration range under study with r2 value 0.999 and 0.996 for DS and DC respectively in ratio derivative spectroscopy and 0.998 and 0.999 for DS and DC respectively in LC-DAD study. Both of these methods are found to be accurate and precise, though greater robustness and precision is observed with chromatographic analysis over the ratio derivative spectroscopy. Statistically there was no significant difference between proposed ratio derivative spectrophotometric and LC-DAD methods.

摘要 双氯芬酸钠（Diclofenac sodium，DS）与双醋瑞因（Diacerein，DC）已成为治疗膝骨关节炎的潜在联合疗法。因此，建立经验证的分析方法以同时定量测定复方制剂中的两种成分至关重要。本研究开发了比值导数分光光度法与色谱技术两种分析方法，用于同时测定DS与DC的含量：第一种方法分别于263.00 nm处定量DC、304.50 nm处定量DS；色谱法（液相色谱-二极管阵列检测器法，LC-DAD）则以醋酸盐缓冲液与甲醇作为流动相，流速为0.50 mL/min，于257 nm处定量DC、274 nm处定量DS。两种方法在考察浓度范围内均呈良好线性关系：比值导数分光光度法中，DS与DC的决定系数r²分别为0.999与0.996；LC-DAD法中，DS与DC的r²分别为0.998与0.999。两种方法均具备良好的准确度与精密度，且相较于比值导数分光光度法，色谱分析展现出更优的耐用性与精密度。统计学分析表明，所提出的比值导数分光光度法与LC-DAD法之间无显著性差异。