The stability method and analysis of diphenhydramine hydrochloride in liquid and solid drug dosage forms.
Item
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Title
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The stability method and analysis of diphenhydramine hydrochloride in liquid and solid drug dosage forms.
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Identifier
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AAI9000744
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identifier
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9000744
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Creator
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Yuan, Hai-Ping.
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Contributor
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Adviser: David C. Locke
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Date
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1989
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Language
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English
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Publisher
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City University of New York.
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Subject
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Chemistry, Analytical | Chemistry, Pharmaceutical
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Abstract
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Diphenhydramine hydrochloride in two different drug dosage forms--one in liquid form and the other in solid form--was chosen as the active for the demonstration of this study. One can obtain these Over-The-Counter (OTC) drugs without a prescription. The study is comprised of two parts. PART ONE is the development and suitability check of the analytical method for accurately quantitating diphenhydramine hydrochloride component in both pharmaceutical products. A reversed-phase ion-pair liquid chromatographic method was developed. The precision, linearity, specificity and recovery were checked, and proved to be suitable for stability analysis of diphenhydramine hydrochloride in these pharmaceutical products. PART TWO is the thermal kinetic study of the active compound. Drug samples were stored at 42, 52 and 62{dollar}\sp\circ{dollar}C for times up to about 110 days. The method used for quantitation of the active compound in untreated and thermally treated samples was the reversed-phase ion-pair HPLC method developed in PART ONE. The decomposition rate constant of the compound was determined first through the time-based kinetic approaches by plotting the active levels vs. time for each storage temperature. Then the decomposition rate at room temperature can be predicted by the extrapolation of the Arrhenius plot, hence the shelf life of the drug compound at 25{dollar}\sp\circ{dollar}C can be calculated.
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Type
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dissertation
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Source
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PQT Legacy CUNY.xlsx
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degree
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Ph.D.
