A review on analytical profile for newly FDA approved drugs in 2023

Pusuluri Siva Krishna, Munnangi Mukkanti Eswarudu, Puttagunta Srinivasa Babu, Tadepalli Likhitha, Narayanapuram Venkatesh, Chintamaneni Poojitha, Kurapati Sujana, Bellamkonda Gopaiah
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Abstract

In 2023, the field of pharmaceuticals witnessed the approval of several novel drugs by the United States Food and Drug Administration (USFDA). These drugs represent significant advancements in the treatment of various medical conditions and have undergone rigorous evaluation to ensure their safety and efficacy. To support their development and subsequent quality control, a variety of analytical methods have been employed. This review highlights the analytical methods employed for the evaluation and quality control of FDA approved drugs. These methods encompass a range of techniques that enable the characterization, quantification, and quality assessment of pharmaceutical compounds. Commonly employed analytical techniques include chromatographic methods such as high-performance liquid chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), Ultra-Performance Liquid Chromatography (UPLC), Ultra-high-performance liquid chromatography (UHPLC), Ultra- performance liquid chromatography-Mass Spectrometry (UPLC-MS). The Approved Drugs are Bexagliflozin (Sodium-glucose Cotransporter 2 Inhibitor (SGLT2)), Daprodustat (Hypoxia-inducible factor prolyl hydroxylase inhibitor), Valmanasealfa-tycv (Recombinant human lysosomal alpha-mannosidase), Rezafungin(Echinocandin antifungal drug), Sparsentan (Dual endothelin and angiotensin II receptor antagonist), Nirmatrelvir (Anti-viral), Ritonavir (Protease Inhibitors). Overall, the approval of FDA drugs in 2023 relied on the utilization of diverse and robust analytical methods. These methods facilitated the rigorous assessment of drug quality, safety, and efficacy, ensuring that patients receive reliable and effective treatments. The continuous advancement of analytical techniques will further contribute to the development and evaluation of innovative pharmaceuticals in the future.
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2023年FDA新批准药物分析概况综述
2023年,制药领域见证了美国食品和药物管理局(USFDA)批准了几种新药。这些药物在治疗各种疾病方面取得了重大进展,并经过严格的评估,以确保其安全性和有效性。为了支持其开发和随后的质量控制,采用了多种分析方法。本文综述了FDA批准的药品评价和质量控制所采用的分析方法。这些方法包括一系列能够对药物化合物进行表征、定量和质量评估的技术。常用的分析技术包括高效液相色谱法(HPLC)、液相色谱-质谱法(LC-MS)、超高效液相色谱法(UPLC)、超高效液相色谱-质谱法(UPLC- ms)等色谱方法。批准的药物是Bexagliflozin(钠-葡萄糖共转运蛋白2抑制剂(SGLT2))、Daprodustat(缺氧诱导因子丙氨酸羟化酶抑制剂)、Valmanasealfa-tycv(重组人溶酶体α -甘露糖苷酶)、Rezafungin(包皮白蛋白抗真菌药物)、Sparsentan(双重内皮素和血管紧张素II受体拮抗剂)、Nirmatrelvir(抗病毒药物)、Ritonavir(蛋白酶抑制剂)。总的来说,2023年FDA药物的批准依赖于使用多样化和强大的分析方法。这些方法促进了对药物质量、安全性和有效性的严格评估,确保患者获得可靠和有效的治疗。分析技术的不断进步将进一步促进未来创新药物的开发和评价。
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