Shiek Abdul Kadhar Mohamed Ebrahim Habibur Rahman, Chungath Telny Thomas, Sridhar Karthik, Siram Karthik, Elumalai Manogaran, Ranganathan Hariprasad, Muthusamy Sivaselvakumar
PSG College of Pharmacy, Department of Pharmaceutics, Coimbatore, India
Chemists College of Pharmaceutical Sciences and Research, Department of Pharmaceutical Analysis, Ernakulum, India
Turk J Pharm Sci. 2021 Oct 28;18(5):565-573. doi: 10.4274/tjps.galenos.2021.91145.
The present study aimed to develop and validate a discriminative dissolution method for tetrahydrocurcumin (THC), a Biopharmaceutical Classification System class II drug, by a simple ultraviolet (UV) spectrophotometric analysis. The final dissolution medium composition was selected based on the solubility and stability criteria of the drug.
As a prerequisite for this, the solubility of the drug was assessed in media of different pH (1.2-7.4), and surfactant concentrations of 0.5-1.5% (w/v) sodium lauryl sulfate (SLS) in water, and pH 7.4 phosphate buffer. The dissolved drug concentration in each medium was quantified by UV analysis at 280 nm wavelength.
The drug solubility was found to be high at a pH of 1.2 and 7.4. The media with surfactant enhanced solubility of the drug by approximately 17-fold and exhibited better sink conditions. The discriminative power of the developed dissolution medium (i.e., 1% w/v SLS in pH 7.4) was determined by performing dissolution studies of the prepared THC tablets and comparing their release profiles using fit factors (f1 and f2). The results of the fit factor comparisons made between the dissolution profiles of THC tablets proved the discriminative ability of the medium. The validation of the developed dissolution method was performed by international guidelines and the method showed specificity, linearity, accuracy, and precision within the acceptable range.
The proposed dissolution method was found to be adequate for the routine quality control analysis of THC, as there is no specified dissolution method for the drug in the pharmacopoeia.
本研究旨在通过简单的紫外分光光度分析，开发并验证一种用于生物药剂学分类系统II类药物四氢姜黄素（THC）的区分性溶出方法。最终的溶出介质组成是根据药物的溶解度和稳定性标准选择的。
作为前提条件，评估了该药物在不同pH值（1.2 - 7.4）的介质、水中0.5 - 1.5%（w/v）十二烷基硫酸钠（SLS）以及pH 7.4磷酸盐缓冲液中的溶解度。通过在280 nm波长处的紫外分析对每种介质中溶解的药物浓度进行定量。
发现该药物在pH 1.2和7.4时溶解度较高。含有表面活性剂的介质使药物溶解度提高了约17倍，并呈现出更好的漏槽条件。通过对制备的THC片剂进行溶出度研究，并使用拟合因子（f1和f2）比较其释放曲线，确定了所开发溶出介质（即pH 7.4的1% w/v SLS）的区分能力。THC片剂溶出曲线之间的拟合因子比较结果证明了该介质的区分能力。所开发的溶出方法按照国际指南进行了验证，该方法在可接受范围内显示出特异性、线性、准确性和精密度。
由于药典中没有该药物的特定溶出方法，所提出的溶出方法被认为适用于THC的常规质量控制分析。
