In this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should be applied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and their metabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigated to decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of set up to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double mass spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic methods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy, precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed to add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug, concentration and its metabolite.
Objective: Domperidone is a synthetic benzimidazole compound that acts as a dopamine D 2 receptor antagonist. The main aim of this study was to optimize and evaluate the floating tablets of domperidone that prolongs the gastric residence time using Hibiscus rosa-sinensis mucilage. Methods:The directly compressible floating tablets of domperidone were formulated using varying amount of hydroxypropyl methylcellulose K100 M, carbopol 934P and H. rosa-sinensis mucilage. The effervescent components sodium bicarbonate is used for the generation of CO 2 gas. The prepared tablets were evaluated for physicochemical parameters and found to be within range, viz., hardness, swelling index, floating capacity, thickness, and weight variation. Further, tablets were evaluated for in vitro release characteristics. The concentration of H. rosa-sinensis mucilage with a gas-generating agent was optimized to get the sustained release of domperidone. Result:The % cumulative drug release of all formulation from F1 to F6 was within the range of 81.37% to 98.62% for 18 hrs. The release kinetics of all the dosage forms was calculated using zero order, first order, Higuchi, and Korsmeyer-Peppas. It concludes that the release followed zero order release, whereas the correlation coefficient (r 2 value) was higher for zero order release. The release mechanism follows Higuchi model, KorsmeyerPeppas model, and non-Fickian diffusion. Conclusion:As a result of this study, it may be concluded that the floating tablets using H. rosa-sinensis mucilage in optimized concentrations can be used to increase the gastric retention time of the dissolution fluid in the stomach to deliver the drug in a sustained manner. Furthermore, from 1 month stability data shows no significant change compared to initial result.
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