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

Department of Pharmaceutical Analysis,Vignan Pharmacy College, Vadlamudi, 522213, Andhra Pradesh, India.

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Pusuluri Siva Krishna, Munnangi Mukkanti Eswarudu, Puttagunta Srinivasa Babu, Tadepalli Likhitha, Narayanapuram Venkatesh, Chintamaneni Poojitha, Kurapati Sujana, Bellamkonda Gopaiah, 2023. A review on analytical profile for newly FDA approved drugs in 2023. Journal of medical pharmaceutical and allied sciences, V 12 - I 4, Pages - 5955 – 5961. Doi: https://doi.org/10.55522/jmpas.V12I4.5491

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.

Keywords:

HPLC, LC-MS, UPLC, UHPLC, UPLC-MS

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