Stability of selected pharmaceuticals in polypropylene syringes at ambient temperature and 4 degrees celsius ; development of high-performance liquid chromatography assays for selected pharmaceuticals in dosage form and human plasma
Storms, Meredith W
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Part I (Chapters 1-6) of this dissertation describes the use of stability-indicating HPLC methods for ephedrine sulfate, lidocaine hydrochloride, neostigmine methylsulfate, glycopyrrolate, succinylcholine chloride, and tubocurarine chloride stored individually in polypropylene syringes at ambient temperature (24±1°C) or under refrigeration for either 60 or 90 days.|In Part II, HPLC is employed for the analysis of selected pharmaceuticals in dosage forms and human plasma studies.|Chapter 7 reports an assay for the simultaneous determination of guaifenesin-pseudoephedrine- dextromethorphan and guaifenesin-pseudoephedrine in commercially available capsule dosage forms and guaifenesin-codeine in a commercial cough syrup dosage form. For each drug mixture, the separation was achieved within 10 minutes. The method showed linearity for the guaifenesin-pseudoehedrine-dextromethorphan mixture in the 50-200, 7.5-30, and 2.5-10 mg/ml ranges, respectively. The guaifenesin-pseudoephedrine mixture yielded linear ranges of 25-100 and 3.75-15 mg/ml, respectively. The method showed linearity for the guaifenesin-codeine mixture in the 25-100 and 2.5 to 10 mg/ml ranges, respectively. The intra- and inter-day precision and precision for the analytes in each mixture ranged from 0.13-5.04%.|Chapter 8 describes a stability-indicating HPLC assay for the separation and quantitation of epinephrine-prilocaine and epinephrine-procaine combinations in their respective dosage forms. The method showed linearity for the epinephrine-prilocaine mixture in the 0.25-2.5 and 8-200 mg/ml ranges, respectively. The intra- and inter-day RSDs ranged from 0.26 to 2.05% and 0.04 to 0.61% for epinephrine and prilocaine, respectively. The epinephrine and procaine mixture yielded linear ranges of 0.25-2.0 and 5-100 mg/ml ranges, respectively. The intra- and inter-day RSDs ranged from 0.3 to 1.88 and 0.07 to 0.26% for epinephrine and procaine, respectively. Stability-indicating HPLC assays were also developed for levonordefrin-tetracaine-procaine, levonordefrin-procaine- propoxycaine, and norepinephrine-procaine-propoxycaine drug combinations.|Chapter 9 describes an HPLC method for the determination of amoxicillin, metronidazole, and pantoprazole in human plasma. Solid-phase extraction was employed to extract the analytes along with the internal standard (tinidazole). Limits of detection were 200 ng/ml for amoxicillin and metronidazole and 100 ng/ml for pantoprazole. Recoveries from human plasma ranged from 83-92% for amoxicillin, 81-89% for metronidazole, 85-94% for tinidazole, and 93-101% for pantoprazole. Intra-day (n=5) and inter-day (n=15) precision (%RSD) and accuracy (%error) for analytes ranged from 1.11-5.97% and 0.72-13.5%, respectively.