Simultaneous Estimation of Amoxycillin and Potassium Clavulanate in Injection Formulation by RP-HPLC

Adarsh Kumar Pathak, Akhilesh Gupta
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Abstract

Amoxycillin (AMX) and Potassium clavulanate (PTC) are proven for their therapeutic benefits to treats various diseases. AMX and PTC are proven for their therapeutic benefits to treat various diseases. Due to their synergistic actions, a rapid and specific RP-HPLC method was processed and validated as per ICH guidelines. The chromatographic separation was performed with Inertsil 5μ, 250 mm X 4.6 mm, C-18 HPLC column by using phosphate buffer: methanol (80:20) as mobile phase, at 1mL/min of flow rate and 220nm m. The absorption maxima were found to be 246.6 nm for AMX and 257.6 nm for PTC in 0.1M NaOH used as the solvent. The linearity for these drugs at the selected wavelengths lies between 5-200 µg/ml for AMX and 5-200 µg/ml for PTC. Accuracy was determined by recovery study from injection dosages forms were found to be 99.352 for AMX and 99.533 for PTC. Precision of method was determined as repeatability, day to day and analyst to analyst variation and a show the value within acceptable limit i.e. R.S.D was found to be less than 2 percent).
反相高效液相色谱法测定注射剂型中阿莫西林和克拉维酸钾的含量
阿莫西林(AMX)和克拉维酸钾(PTC)被证明具有治疗各种疾病的疗效。AMX和PTC治疗多种疾病的疗效已被证实。由于它们的协同作用,根据ICH指南,建立了一种快速、特异的反相高效液相色谱方法。色谱柱为Inertsil 5μ, 250 mm × 4.6 mm, C-18高效液相色谱柱,流动相为磷酸缓冲液:甲醇(80:20),流速为1mL/min,流速为220nm m,以0.1M NaOH为溶剂,AMX和PTC的最大吸光度分别为246.6 nm和257.6 nm。在所选波长下,这些药物的线性关系在AMX的5-200µg/ml和PTC的5-200µg/ml之间。通过对注射剂型的回收率研究确定了准确度,发现AMX的回收率为99.352,PTC的回收率为99.533。方法的精度被确定为可重复性,每天和分析师对分析师的变化,并显示在可接受范围内的值,即rsd被发现小于2%)。
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