Awad Hanan, Aboul-Enein Hassan Y, Lashin Sherif
Methodology Department, Research and Development Sector, Sigma Pharmaceutical Industries, 1st Quarter, Mubarak Industrial Zone, Quesna, El Monofeya, Egypt.
Biomed Chromatogr. 2012 Apr;26(4):502-6. doi: 10.1002/bmc.1694.
A high-performance liquid chromatography-diode array detector (HPLC-DAD) method was developed and validated for the quantitation of dexibuprofen in dexibuprofen tablets using ovomucoid chiral stationary phase (Ultron ES-OVM). The mobile phasewas composed of 0.025 M potassium phosphate dibasic (pH 4.5)-methanol-ethanol (85:10:5 v/v/v). The method was validated for specificity, linearity, range, accuracy, precision and robustness. The method was enantiomerspecific for the determination of dexibuprofen [S-(+)-isomer ibuprofen] in the presence of R-(-)-isomer ibuprofen in bulk drug, pharmaceutical dosage form and under stress degradation. The method was linear over the range 15-35 mg/mL with r² = 0.9995; accuracy and precision were acceptable with %RSD < 2.0%. The method was found to be specific, precise, accurate, robust and stability-indicating, and can be successfully applied for the routine analysis of dexibuprofen in bulk drug and pharmaceutical dosage form.
建立了一种高效液相色谱 - 二极管阵列检测器（HPLC - DAD）方法，并使用卵类粘蛋白手性固定相（Ultron ES - OVM）对右旋布洛芬片中的右旋布洛芬进行定量分析及方法验证。流动相由0.025 M磷酸氢二钾（pH 4.5）-甲醇 - 乙醇（85:10:5 v/v/v）组成。该方法在特异性、线性、范围、准确度、精密度和耐用性方面进行了验证。该方法在原料药、药物剂型及加速降解条件下，对存在R - (-)-异构体布洛芬的情况下测定右旋布洛芬[S - (+)-异构体布洛芬]具有对映体特异性。该方法在15 - 35 mg/mL范围内呈线性，r² = 0.9995；准确度和精密度可接受，相对标准偏差（%RSD）< 2.0%。该方法具有特异性、精密、准确、耐用且能指示稳定性，可成功应用于原料药和药物剂型中右旋布洛芬的常规分析。
