Gujral Rajinder Singh, Haque Sk Manirul
Vardhman Life Sciences Pvt. Ltd., A-7, Sipcot Industrial Complex, Cuddalore (Tamilnadu), India.
Int J Biomed Sci. 2010 Dec;6(4):335-43.
A simple and sensitive UV spectrophotometric method was developed and validated for the simultaneous determination of Potassium Clavulanate (PC) and Amoxicillin Trihydrate (AT) in bulk, pharmaceutical formulations and in human urine samples. The method was linear in the range of 0.2-8.5 μg/ml for PC and 6.4-33.6 μg/ml for AT. The absorbance was measured at 205 and 271 nm for PC and AT respectively. The method was validated with respect to accuracy, precision, specificity, ruggedness, robustness, limit of detection and limit of quantitation. This method was used successfully for the quality assessment of four PC and AT drug products and in human urine samples with good precision and accuracy. This is found to be simple, specific, precise, accurate, reproducible and low cost UV Spectrophotometric method.
开发并验证了一种简单且灵敏的紫外分光光度法，用于同时测定原料药、药物制剂及人体尿液样本中的克拉维酸钾（PC）和三水合阿莫西林（AT）。该方法对PC的线性范围为0.2 - 8.5μg/ml，对AT的线性范围为6.4 - 33.6μg/ml。分别在205nm和271nm处测定PC和AT的吸光度。该方法在准确度、精密度、特异性、耐用性、稳健性、检测限和定量限方面得到了验证。该方法成功用于四种PC和AT药品的质量评估以及人体尿液样本分析，具有良好的精密度和准确度。这是一种简单、特异、精密、准确、可重现且成本低廉的紫外分光光度法。
