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Ultraviolet spectrophotometry (dual wavelength and chemometric) and high performance liquid chromatography for simultaneous estimation of meropenem and sulbactam sodium in pharmaceutical dosage form

机译:紫外分光光度法(双波长和化学计量)和高效液相色谱法,用于同时估算药物剂型中美罗培南和舒巴坦钠

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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 0.1 N sodium hydroxide as solvent. The Beer's plot for dual wavelength method was linear in the range of 4-24 μgmL~(-1) and 2-12 μgmL~(-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 μgmL~(-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.
机译:开发了紫外分光光度法和高效液相色谱(HPLC)方法,用于同时测定注射液中美罗培南(MERM)和舒巴坦钠(SB)的方法。紫外分光光度法是使用0.1 N氢氧化钠作为溶剂开发的。对于MERM和SB,双波长方法的比尔曲线分别在4-24μgmL〜(-1)和2-12μgmL〜(-1)范围内。发现MERM和SB的回收率分别为98.52±1.23%和101.45±1.1%。化学计量学辅助的紫外分光光度法使用偏最小二乘(PLS)分析模型和主成分回归(PCR)分析模型进行。使用PLS和PCR测定的MERM回收率分别为100.61±0.06%和101.31±0.12%。使用PLS和PCR发现SB的回收率分别为98.29±0.09%和97.61±0.13%。在Hypersil BDS C18柱上进行色谱分离,使用甲醇:乙腈:水(10:20:70 v / v / v)作为流动相。发现MERM和SB的保留时间分别为2.9分钟和2.25分钟。已开发的HPLC方法对于MERM和SB分别在50-250μgmL〜(-1)和25-125μgmL〜(-1)范围内呈线性。发现MERM和SB的回收率分别为98.85±0.25%和98.63±0.34%。当用于药物剂型时,开发的分析方法未显示赋形剂的任何干扰。

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