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Rapid and Sensitive Liquid Chromatographic Method for Determination of Anastrozole in Different Polymer–Lipid Hybrid Nanoparticles
SLAS Technology: Translating Life Sciences Innovation ( IF 2.5 ) Pub Date : 2021-01-12 , DOI: 10.1177/2472630320982308
Dilshad Ahmad 1, 2 , Faisal A Al Meshaiti 1 , Yazeed K Al Anazi 1 , Osama Al Owassil 1, 2 , Alaa Eldeen B Yassin 1, 2
Affiliation  

Anastrozole, an aromatase inhibitor drug, is used for the treatment of breast cancer in pre- and postmenopausal women. Anastrozole’s incorporation into nanoparticulate carriers would enhance its therapeutic performance. To perceive the exact loaded amount of drug in nanocarriers, a valid analytical method is required. The reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated by using the C18 column, 150 × 4.6 mm, 5 µm particle size, in isocratic mobile phase composed of 50:50 V/V (volume/volume) acetonitrile–phosphate buffer (pH 3) flowing at a rate of 1.0 mL/min, and a diode array detector (DAD) set at λmax = 215 nm. The validation parameters such as linearity, accuracy, specificity, precision, and robustness have proven the accuracy of the method, with the relative standard deviation percentage (% RSD) values < 2. The limit of detection of the method was found equal to 0.0150 µg/mL, and the limit of quantitation was 0.0607 µg/mL. The percent recovery of sample was in the range of 98.04–99.25%. The method has the advantage of being rapid with a drug retention time of 2.767 min, specific in terms of resolution of peaks void of interference with any of the excipients, and high reproducibility. This makes it highly applicable for quality control purposes.



中文翻译:

快速、灵敏的液相色谱法测定不同聚合物-脂质杂化纳米颗粒中的阿那曲唑

阿那曲唑是一种芳香酶抑制剂药物,用于治疗绝经前和绝经后妇女的乳腺癌。阿那曲唑掺入纳米颗粒载体将增强其治疗性能。为了感知纳米载体中药物的准确负载量,需要一种有效的分析方法。反相高效液相色谱 (RP-HPLC) 方法是通过使用 C18 色谱柱,150 × 4.6 mm,5 µm 粒径,在由 50:50 V/V(体积/体积)乙腈-磷酸盐缓冲液(pH 3),流速为 1.0 mL/min,二极管阵列检测器 (DAD) 设置为 λmax = 215 nm。线性、准确度、特异性、精密度和稳健性等验证参数证明了方法的准确性,相对标准偏差百分比 (% RSD) 值 < 2。发现该方法的检测限等于 0.0150 µg/mL,定量限为 0.0607 µg/mL。样品的百分比回收率在 98.04-99.25% 的范围内。该方法的优点是快速,药物保留时间为 2.767 分钟,在峰的分辨率方面具有特异性,不受任何赋形剂的干扰,并且重现性高。这使得它非常适用于质量控制目的。峰的分辨率不受任何赋形剂的干扰,重现性高。这使得它非常适用于质量控制目的。峰的分辨率不受任何赋形剂的干扰,重现性高。这使得它非常适用于质量控制目的。

更新日期:2021-01-13
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