Marwada Kuldip R, Patel Jigar B, Patel Nisarg S, Patel Bhargav D, Borkhatariya Dharnant V, Patel Archita J
Department of Quality Assurance, K.B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwavidhyalaya, Sector-23, Gh-6, Gandhinagar, Gujarat, India.
Ramanbhai Patel College of Pharmacy, CHARUSAT, Changa, Gujarat, India.
Spectrochim Acta A Mol Biomol Spectrosc. 2014 Apr 24;124:292-9. doi: 10.1016/j.saa.2014.01.008. Epub 2014 Jan 17.
UV spectrophotometric and high performance liquid chromatography (HPLC) methods were developed for simultaneous determination of meropenem (MERM) and sulbactam sodium (SB) in injection. UV spectrophotometric methods were developed using 0.1N sodium hydroxide as solvent. The Beer's plot for dual wavelength method was linear in the range of 4-24 μg mL(-1) and 2-12 μg mL(-1) for MERM and SB, respectively. The percent recoveries were found to be 98.52±1.23% for MERM and 101.45±1.1% for SB. Chemometrics assisted UV spectrophotometry was performed using Partial Least Square (PLS) analysis model and Principal Component Regression (PCR) analysis model. The % recoveries of the MERM were found to be 100.61±0.06% and 101.31±0.12% using PLS and PCR, respectively. The % recoveries of the SB were found to be 98.29±0.09% and 97.61±0.13% using PLS and PCR, respectively. Chromatography was performed on Hypersil BDS C18 column using methanol:acetonitrile:water (10:20:70 v/v/v) as mobile phase. The retention times of MERM and SB were found to be 2.9 min and 2.25 min, respectively. Developed HPLC method was found to be linear in the range of 50-250 μg mL(-1) and 25-125 μg mL(-1) for MERM and SB, respectively. The % recoveries were found to be 98.85±0.25% and 98.63±0.34% for MERM and SB, respectively. The developed analytical methods did not show any interference of the excipients when applied to pharmaceutical dosage form.
建立了紫外分光光度法和高效液相色谱法（HPLC）同时测定注射剂中美罗培南（MERM）和舒巴坦钠（SB）的含量。采用0.1N氢氧化钠作为溶剂建立紫外分光光度法。双波长法的比尔定律曲线在美罗培南浓度为4 - 24μg mL⁻¹、舒巴坦钠浓度为2 - 12μg mL⁻¹范围内呈线性。美罗培南的回收率为98.52±1.23%，舒巴坦钠的回收率为101.45±1.1%。采用偏最小二乘法（PLS）分析模型和主成分回归（PCR）分析模型进行化学计量学辅助紫外分光光度法。使用PLS和PCR时，美罗培南的回收率分别为100.61±0.06%和101.31±0.12%。使用PLS和PCR时，舒巴坦钠的回收率分别为98.29±0.09%和97.61±0.13%。采用甲醇:乙腈:水（10:20:70 v/v/v）作为流动相，在Hypersil BDS C18柱上进行色谱分析。美罗培南和舒巴坦钠的保留时间分别为2.9分钟和2.25分钟。所建立的HPLC方法在美罗培南浓度为50 - 250μg mL⁻¹、舒巴坦钠浓度为25 - 125μg mL⁻¹范围内呈线性。美罗培南和舒巴坦钠的回收率分别为98.85±0.25%和98.63±0.34%。所建立的分析方法应用于药物剂型时未显示出任何辅料的干扰。
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