Sonawane P H, Panzade P S, Kale M A
Department of Chemistry, Government College of Pharmacy, Osmanpura, Aurangabad-431 005, India.
Indian J Pharm Sci. 2013 Mar;75(2):230-3.
The simple, selective, precise and accurate reverse-phase high-performance liquid chromatography method was developed and validated for analysis of tadalafil in bulk and tablet dosage form. The column was Inertsil C18 (150×4.6 mm; 5 μm) in isocratic mode. The mobile phase used was phosphate buffer (10 mM, pH 3.2) and acetonitrile (50:50% v/v) at the flow rate of 1.0 ml/min with ultraviolet detection at 295 nm at ambient temperature. The retention time for tadalafil was found to be 4.01 min. Linearity was observed in the concentration range from 60 to 140 μg/ml for tadalafil with a correlation coefficient of (r (2)) 0.9998. The method was validated according to International Conference on Harmonisation guidelines in terms of linearity, accuracy, precision and specificity. Hence, the proposed method can be utilized for routine quality control of tadalafil in bulk and tablet dosage form.
开发并验证了一种简单、选择性好、精确且准确的反相高效液相色谱法，用于分析原料药和片剂剂型中的他达拉非。色谱柱为Inertsil C18（150×4.6 mm；5μm），采用等度洗脱模式。所用流动相为磷酸盐缓冲液（10 mM，pH 3.2）和乙腈（50:50% v/v），流速为1.0 ml/min，在室温下于295 nm处进行紫外检测。他达拉非的保留时间为4.01分钟。他达拉非在60至140μg/ml的浓度范围内呈现线性，相关系数（r (2)）为0.9998。该方法根据国际协调会议指南在线性、准确度、精密度和专属性方面进行了验证。因此，所提出的方法可用于他达拉非原料药和片剂剂型的常规质量控制。
