College of Pharmacy, King Saud Bin Abdul Aziz University for Health Sciences, Riyadh, Saudi Arabia.
King Abdullah International Research Center, National Guard Health Affairs, Riyadh, Saudi Arabia.
SLAS Technol. 2021 Aug;26(4):384-391. doi: 10.1177/2472630320982308. Epub 2021 Jan 12.
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.
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。将阿那曲唑纳入纳米载体中会增强其治疗性能。为了准确感知纳米载体中药物的实际载药量，需要一种有效的分析方法。本文采用 C18 柱（150×4.6mm，5μm 粒径），在等度流动相中，以 50:50（体积/体积）的乙腈-磷酸盐缓冲液（pH3）为流动相，流速为 1.0mL/min，二极管阵列检测器（DAD）设置在 λmax = 215nm 的条件下，建立并验证了反相高效液相色谱（RP-HPLC）方法。该方法的线性、准确度、专属性、精密度和稳健性等验证参数均证明了方法的准确性，相对标准偏差（%RSD）值均<2。该方法的检测限为 0.0150μg/mL，定量限为 0.0607μg/mL。样品的回收率在 98.04%-99.25%范围内。该方法具有快速（药物保留时间为 2.767min）、专属性（无任何辅料干扰的峰分离度）和重现性好的优点。因此，该方法非常适用于质量控制目的。
