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可持续的紫外线方法得到了绿色和白色评估的支持,用于估计最近 FDA 批准的一种用于治疗泌尿科疾病的组合:Tukey 检验。

Sustainable UV approaches supported by greenness and whiteness assessments for estimating a recently FDA-approved combination for managing urologic disorders: Tukey's test.

机构信息

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, Cairo 11829, Egypt.

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, Cairo 11829, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2024 Jan 15;305:123551. doi: 10.1016/j.saa.2023.123551. Epub 2023 Oct 15.

Abstract

Erectile dysfunction caused by a urinary tract infection and an enlarged prostate is a common problem among men nowadays. A brand-new FDA-approved combination of finasteride (FNS) and tadalafil (TDF) is currently recommended, particularly for those with prostatic problems in addition to erectile dysfunction. TDF boosts FNS's short-term efficacy in addition to treating erectile dysfunction, one of the sexual adverse effects typically associated with FNS therapy. Accordingly, this research introduces three straightforward spectrophotometric techniques for determining FNS and TDF in their pure and pharmaceutical forms concurrently, in addition to providing a dissolution study for their formulation as per the FDA's directions. FNS and TDF have superimposed UV spectra, making direct concurrent analysis of these medications impossible. To resolve this overlap, we utilized the following UV techniques: the dual-wavelength method, the deconvoluted Fourier method, and the ratio difference method, with linear ranges of (0.50-15) µg/mL for TDF and (5-100) µg/mL for FNS. The LODs ranged from (0.12-0.15) µg/mL and (0.88-1.14) µg/mL, while the LOQs ranged from (0.37-0.46) µg/mL and (2.66-3.45) µg/mL for TDF and FNS, respectively. The proposed techniques were verified as per ICH recommendations and compared statistically to the published approach using three statistical tests. A complete green profile was provided to assess the foregoing techniques' greenness using four metrics, along with the whiteness assessment using the RGB algorithm. The foregoing UV methods have been demonstrated to be sustainable, highly sensitive, specific, and suitable for quality assurance testing.

摘要

由尿路感染和前列腺增生引起的勃起功能障碍是当今男性常见的问题。目前,美国食品和药物管理局(FDA)批准了一种全新的非那雄胺(FNS)和他达拉非(TDF)联合用药方案,特别适用于除勃起功能障碍外还有前列腺问题的患者。TDF 除了治疗勃起功能障碍这一通常与 FNS 治疗相关的性不良反应之外,还能增强 FNS 的短期疗效。因此,本研究介绍了三种简单的分光光度技术,可同时测定纯品和制剂中 FNS 和 TDF 的含量,并按照 FDA 的要求对其制剂进行了溶出度研究。FNS 和 TDF 的紫外光谱有重叠,因此无法直接进行这两种药物的同时分析。为了解决这一重叠问题,我们使用了以下紫外技术:双波长法、解卷积傅里叶法和比值差法,其线性范围分别为 TDF 的(0.50-15)μg/mL 和 FNS 的(5-100)μg/mL。检测限范围分别为 TDF 的(0.12-0.15)μg/mL 和 FNS 的(0.88-1.14)μg/mL,定量限范围分别为 TDF 的(0.37-0.46)μg/mL 和 FNS 的(2.66-3.45)μg/mL。所提出的方法均按照 ICH 建议进行了验证,并通过三个统计检验与已发表的方法进行了统计学比较。使用四个指标对上述技术的绿色度进行了全面评估,并使用 RGB 算法对其白度进行了评估。上述紫外方法已被证明是可持续的、高灵敏度的、特异性的,适合质量保证测试。

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