Development and Validation of a Discriminative Dissolution Medium for a Poorly Soluble Nutraceutical Tetrahydrocurcumin

Autor:	Manogaran Elumalai, Habibur Rahman Shiek Abdul Kadhar Mohamed Ebrahim, Hariprasad Ranganathan, Sivaselvakumar Muthusamy, Karthik Siram, Karthik Sridhar, Telny Thomas Chungath
Rok vydání:	2021
Předmět:	Drug Chromatography In vitro dissolution Chemistry Sodium media_common.quotation_subject Phosphate buffered saline Pharmaceutical Science chemistry.chemical_element Nutraceutical Pulmonary surfactant Molecular Medicine Original Article Solubility Dissolution media_common
Zdroj:	Turk J Pharm Sci
ISSN:	2148-6247 1304-530X
Popis:	OBJECTIVES: 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. MATERIALS AND METHODS: 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. RESULTS: 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 in vitro 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. CONCLUSION: 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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4bca1f4b5e90cc1531284bc882741b00 https://doi.org/10.4274/tjps.galenos.2021.91145 Zobrazit plný text záznamu Plný text ve formátu PDF