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首页> 美国卫生研究院文献>Acta Pharmaceutica Sinica. B >Assessment by HPLC of the degradation behavior of acitretin under hydrolytic oxidative photolytic and thermal stress conditions
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Assessment by HPLC of the degradation behavior of acitretin under hydrolytic oxidative photolytic and thermal stress conditions

机译：通过HPLC评估阿维A在水解氧化光解和热应力条件下的降解行为

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摘要

Acitretin is a photosensitive oral retinoid with very limited data available on its degradation. The official HPLC method for acitretin determination was insufficient to resolve the degradation products generated during stability studies. Therefore, an isocratic RP-HPLC–UV method was developed for the determination of acitretin in the presence of its related impurities and degradation products. Efficient chromatographic separation was achieved on a Thermo beta-basic column C18 (100 mm×4.6 mm, 5 μm) with mobile phase containing 0.3% (v/v) glacial acetic acid with acetonitrile (ACN) and isopropyl alcohol (IPA) in an isocratic ratio of 70:30 at a flow rate of 1.0 mL/min with the eluent monitored at 360 nm. The method was validated for specificity, linearity, precision, accuracy and robustness. The calibration plot was linear over the concentration range of 50–150 μg/mL with a correlation coefficient (r2) of 0.999. The proposed method was used to investigate the degradation kinetics of acitretin under the different degradative conditions. The degradation rate constant (K), half-life (t1/2), and t90 were calculated. Degradation of acitretin followed pseudo-first-order kinetics. The drug was found to be less stable under acidic and photolytic degradation conditions: the photolytic degradation constants for acitretin in sunlight and UV light were 0.002698% and 0.0008402% min−1, respectively. The LOD for acitretin and the known impurities were at a level below 0.02%. The method shows consistent recoveries for ACTR (99.8%–101.2%) and also for its known impurities (97.2–101.3%). The method was found to be accurate, precise, linear, specific, sensitive, rugged, robust, and useful for characterizing the stability of this chemical.
机译：阿维A是一种光敏性口服类视黄醇，其降解数据非常有限。测定阿维A的官方HPLC方法不足以解决稳定性研究过程中产生的降解产物。因此，开发了一种等度的RP-HPLC-UV方法，用于在存在相关杂质和降解产物的情况下测定阿维A酸。在Thermo beta碱性C18色谱柱（100mm×4.6mm，5μm）上进行高效色谱分离，流动相中含有0.3％（v / v）冰醋酸和乙腈（ACN）和异丙醇（IPA）流速为1.0 mL / min时，等度比为70:30，洗脱液在360 nm处进行监测。验证了该方法的特异性，线性，精密度，准确性和鲁棒性。校准曲线在50–150μg/ mL的浓度范围内呈线性关系，相关系数（r 2 ）为0.999。该方法用于研究阿维A在不同降解条件下的降解动力学。计算降解速率常数（K），半衰期（t1 / 2）和t90。阿维A降解遵循伪一级动力学。发现该药物在酸性和光解降解条件下不稳定：阿维A在阳光和紫外线下的光解常数分别为0.002698％和0.0008402％min -1 。阿维A和已知杂质的检出限低于0.02％。该方法显示出ACTR（99.8％–101.2％）及其已知杂质（97.2–101.3％）的回收率一致。发现该方法是准确，精确，线性，特异性，灵敏，坚固，耐用的，并且对于表征该化学品的稳定性有用。

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