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A Novel Method Development and Validation of Ceftazidime in Bulk Drug and Pharmaceutical Dosage Forms Using RRLC Method
Iranian Journal of Science and Technology, Transactions A: Science ( IF 1.7 ) Pub Date : 2022-08-09 , DOI: 10.1007/s40995-022-01333-2
K. Samuel Barnabas, S. Prashanna Suvaitha, G. Dhinagaran, K. Venkatachalam

The existing conventional pharmacopeial methods generally used by the pharma industry are easy to perform and reasonably priced, but they require a long time and traditional buffers to obtain the results. This technique was discovered to be lacking in ruggedness as a result of the employment of a conventional column and the usage of a dual-buffer mobile phase in the previous study. There are also no methods available for determining the concentration of ceftazidime in a solution using Rapid Resolution Liquid Chromatography. The goal of this research was to develop and evaluate a unique and previously unpublished liquid chromatography technology for the selected drug. The chromatographic elution was achieved through phosphate buffer solution (0.01 mol/L) and acetonitrile (90:10, v/v) and a flow rate of 1.0 mL/min. The retention time was estimated to be 1.7 min with the Agilent Eclipse C8, 100 mm length, 4.6 mm internal diameter, 1.8 μm particle size column with a flow rate of 1.0 mL/min. A photodiode array detector is used to monitor the eluate at 270 nm, and the temperature of the column is maintained at 35 °C. The method validation parameters yielded good results, including range, linearity, precision, accuracy, specificity, and recovery. The calibration curve was linear from 70 to 130 μg/mL, with a correlation coefficient of 0.9994. The inter-day and intra-day precision was less than 1%. The accuracy was studied, and the recovery test indicated a mean absolute of 99.0% and 101.0% for ceftazidime. The degradation products resulting from the stress studies did not interfere with the detection of ceftazidime, and the assay is thus stability-indicating. In the present study, the detection was carried out more rapidly with the Rapid Resolution Liquid Chromatography method than with the traditional high-performance liquid chromatography method, which indicates that this method is both practical and unconventional to be implemented.



中文翻译:

使用 RRLC 方法开发和验证散装药物和药物剂型中的头孢他啶的新方法

制药行业普遍使用的现有常规药典方法易于执行且价格合理,但需要较长时间和传统缓冲才能获得结果。由于在先前的研究中使用传统色谱柱和双缓冲流动相,该技术被发现缺乏耐用性。也没有可用于使用快速分离液相色谱测定溶液中头孢他啶浓度的方法。这项研究的目的是为选定的药物开发和评估一种独特的、以前未发表的液相色谱技术。通过磷酸盐缓冲溶液 (0.01 mol/L) 和乙腈 (90:10, v/v) 以 1.0 mL/min 的流速实现色谱洗脱。使用 Agilent Eclipse C8、100 mm 长、4.6 mm 内径、1.8 μm 粒径色谱柱,流速为 1.0 mL/min,估计保留时间为 1.7 min。光电二极管阵列检测器用于在 270 nm 处监测洗脱液,柱温保持在 35 °C。方法验证参数产生了良好的结果,包括范围、线性、精密度、准确度、特异性和回收率。校准曲线从 70 到 130 μg/mL 呈线性,相关系数为 0.9994。日间和日内精度均小于1%。研究了准确性,回收率测试表明头孢他啶的平均绝对值为 99.0% 和 101.0%。应激研究产生的降解产物不会干扰头孢他啶的检测,因此该测定具有稳定性指示。

更新日期:2022-08-10
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