Rupali B. Giri, Shailesh J. Wadher, Tukaram M. Kalyankar
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引用次数: 0
摘要
本工作的目的是测定片剂含量,对过期和未过期片剂进行溶出度测定,并建立一种简便、选择性、线性、精密度、准确度、灵敏度高的卡维地洛片反相高效液相色谱分析方法。实验采用流动相:20 mM磷酸盐缓冲液(PB) pH为2.5:乙腈(ACN) 55:45 (V/V), pH为2.5,色谱柱(Oyster ODS 3150 -4.6 mM, 5m)和L6 6AD泵。样品体积为20µL,在室温下以1.0 mL min-1的流速注射,运行周期6分钟。用紫外检测器在240 nm处进行检测。样品的保留时间为2.92分钟。在37℃±0.5℃下,在electrolab溶出度仪上进行初步溶出试验。分析结果显示,药物的含量并没有明显的变化。检测发现未过期片剂的比例为94.67%,过期片剂的比例为91.71%。
STUDY OF POST SHELF LIFE AND MARKETED TABLETS OF CARVEDILOL BY RP-HPLC
The purpose of this work was to determine the tablet content and carry out the dissolving test of expired and non-expired tablet as well as establish a simple, selective, linear, precise, accurate and sensitive RP-HPLC technique for the analysis of carvedilol tablets. The experiment was carried out using a mobile phase consisting of 20 mM phosphate buffer (PB) pH 2.5: acetonitrile (ACN) 55:45 (V/V) at a pH of 2.5 using a column (Oyster ODS 3,150-4.6 mm, 5m) and a L6 6AD pump. The sample had a volume of 20 µL, and it was injected at room temperature for a run period of 6 minutes at a flow rate of 1.0 mL min-1. Detection was carried out at 240 nm using an ultraviolet detector. The retention time of the sample was 2.92 minutes. At 37 o C ± 0.5 o C, the preliminary dissolution tests were performed on an Electro Lab dissolution tester. The results of this analysis revealed that there was no distinct shift in the amount of drug present. The percentage of non-expired tablets discovered in the test was 94.67 %, whereas the percentage of expired tablets was 91.71 %.