HPLC-UV Method Validation for Amobarbital and Pharmaceutical Stability Evaluation When Dispersed in a Hyaluronic Acid Hydrogel: A New Concept for Post-Traumatic Osteoarthritis Prevention.

Autor:	Quarterman JC; Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, 115 S Grand Avenue, 201 Pharmacy Building, Iowa City, IA 52242, USA., Naguib YW; Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, 115 S Grand Avenue, 201 Pharmacy Building, Iowa City, IA 52242, USA; Department of Pharmaceutics, Faculty of Pharmacy, Minia University, Minia 61519, Egypt., Chakka JL; Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, 115 S Grand Avenue, 201 Pharmacy Building, Iowa City, IA 52242, USA., Seol D; Department of Orthopedics and Rehabilitation, College of Medicine, University of Iowa, Iowa City, IA 52242, USA., Martin JA; Department of Orthopedics and Rehabilitation, College of Medicine, University of Iowa, Iowa City, IA 52242, USA., Salem AK; Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, 115 S Grand Avenue, 201 Pharmacy Building, Iowa City, IA 52242, USA. Electronic address: aliasger-salem@uiowa.edu.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2022 May; Vol. 111 (5), pp. 1379-1390. Date of Electronic Publication: 2021 Sep 23.
DOI:	10.1016/j.xphs.2021.09.025
Abstrakt:	A mitochondrial electron transport chain member complex I inhibitor, amobarbital, can reduce oxidative damage and chondrocyte death, eventually preventing post-traumatic osteoarthritis (PTOA). Viscosupplementation using a crosslinked hyaluronic acid (HA) hydrogel is currently applied clinically for knee OA pain relief. In this work, we utilized the HA hydrogel as a drug delivery vehicle to improve the long-term efficacy of amobarbital. Here we evaluated the pharmaceutic stability of amobarbital when dispersed in a crosslinked HA hydrogel formulated in proportions intended for clinical use. We validated a high-performance liquid chromatography with an ultraviolet detector (HPLC-UV) method following International Conference for Harmonization Q2(R1) guidelines to ensure its suitability for amobarbital detection. The feasibility of this formulation's drug delivery capability was proven by measuring the release, solubility, and drug uniformity. The amobarbital/HA hydrogel showed comparable amobarbital stability in different biological fluids compared to amobarbital solution. In addition, the amobarbital/HA hydrogel imparted significantly greater drug stability when stored at 70°C for 24 hours. In conclusion, we confirmed the pharmaceutical stability of the amobarbital/HA hydrogel in various conditions and biological fluids using a validated HPLC-UV method. This data provides essential evidence in support of the use of this amobarbital/HA formulation in future clinical trials for PTOA treatment. (Copyright © 2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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