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反相高效液相色谱法同时测定混悬型药物制剂中三氯苯达唑和伊维菌素的方法研究

Development of RP-HPLC Method for Simultaneous Determination of Triclabendazole and Ivermectin in Pharmaceutical Suspension Dosage Form.

作者信息

Rahman Taj Ur, Zaman Ajmal, Bahadur Ali, Zeb Muhammad Aurang, Liaqat Wajiha, Santali Eman Y, Alharthi Sarah, Omar Ruwida M K, Alharthy Saif A, Ali Ashraf

机构信息

Department of Chemistry, Mohi-Ud-Din Islamic University, Nerian Sharif, Azad Jammu and Kashmir, Pakistan.

Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Republic of Korea.

出版信息

J Anal Methods Chem. 2025 Apr 22;2025:5522915. doi: 10.1155/jamc/5522915. eCollection 2025.

Abstract

A reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous determination of triclabendazole (TCB) and ivermectin (IVM) in pharmaceutical dosage form. A mobile phase consisting of acetonitrile/water (50:50 v/v) with a flow rate of 1.5 mL/min was used for chromatographic separation of the mixture of TCB and IVM. The developed method was found to be linear with the correlation coefficient ( = 0.999) for TCB and IVM in the presence of suspension. The limit of quantitation (LOQ), robustness, specificity, accuracy, and precision were validated for the developed method. The peak areas of five replicates of the samples were recorded, and the acceptance rate of suspension recovery was 98%. The intraday accuracies for TCB and IVM were 98.71% and 100.79%, respectively, with a relative standard deviation (RSD) of 0.87%. The limits of detection (LOD) of TCB and IVM were 0.058 mg/mL and 0.112 μg/mL, respectively, while the LOQ of TCB and IVM were 0.178 μg/mL and 0.340 μg/mL, respectively. The method's % RSD for intra- and interday precision was deemed satisfactory. The developed method could be utilized for the determination and measurement of TCB and IVM in other samples.

摘要

建立了一种反相高效液相色谱(RP-HPLC)法,用于同时测定药物剂型中的三氯苯达唑(TCB)和伊维菌素(IVM)。采用乙腈/水(50:50 v/v)组成的流动相,流速为1.5 mL/min,对TCB和IVM的混合物进行色谱分离。结果发现,所建立的方法在有悬浮液存在的情况下,TCB和IVM的线性关系良好,相关系数(r = 0.999)。对所建立的方法进行了定量限(LOQ)、稳健性、特异性、准确性和精密度的验证。记录了样品五次重复的峰面积,悬浮液回收率的接受率为98%。TCB和IVM的日内准确度分别为98.71%和100.79%,相对标准偏差(RSD)为0.87%。TCB和IVM的检测限(LOD)分别为0.058 mg/mL和0.112 μg/mL,而TCB和IVM的定量限分别为0.178 μg/mL和0.340 μg/mL。该方法的日内和日间精密度的RSD%被认为是令人满意的。所建立的方法可用于测定其他样品中的TCB和IVM。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb92/12041623/5d56bbd6403a/JAMC2025-5522915.001.jpg

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