Journal of pharmaceutical and biomedical analysis
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J Pharm Biomed Anal · Feb 2001
The quantification of endogenous steroids in bovine aqueous humour and vitreous humour using isotope dilution GC-NCI-MS.
Pentafluorobenzyloxime-trimethylsilyl derivatives of androgens, progestogens and corticosteroids were prepared and used for the analysis of these steroids in bovine aqueous humour and vitreous humour by GC-MS method. Appropriate deuteriated isotopomers of the parent steroids were labelled with deuterium via simple synthetic procedure and used as internal standards. ⋯ M.) of these steroids in bovine aqueous humour and vitreous humour were found to be as follow: (1) aqueous humour (n = 17); hydrocortisone (n = 17; 2.40 +/- 0.54), progesterone (n = 15; 0.06 +/- 0.01), 4-androstene-3,17-dione (n = 8; 0.15 +/- 0.07) and testosterone (n = 4; 0.14 +/- 0.04); and (2) bovine vitreous humour (n = 19); hydrocortisone (n = 19; 1.78 +/- 0.25), progesterone (n = 18; 0.09 +/- 0.01), 4-androstene-3,17-dione (n = 19; 0.11 +/- 0.02), 11-deoxycorticosterone (n = 12; 29.27 +/- 6.42), 17alpha-hydroxyprogesterone (n = 6; 5.55 +/- 3.12). The concentration of corticosterone, 11-deoxycorticosterone and 17alpha-hydroxyprogesterone and testosterone and corticosterone were below the limit of detection in aqueous humour and vitreous humour, respectively.
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J Pharm Biomed Anal · Sep 2000
Development and validation of a sensitive method for hydromorphone in human plasma by normal phase liquid chromatography-tandem mass spectrometry.
Liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS) was developed for the quantitation of hydromorphone (HYD), an opiate analgesic, in human plasma. A simple liquid-liquid extraction was used to extract the analyte and its deuterated internal standard (d3-HYD). ⋯ D. silica column (5 microm) and a mobile phase of acetonitrile-water formic acid (80:20:1, v/v/v). The method was validated in the concentration range 0.05-10 ng ml(-1) in plasma and met the acceptance criteria of industry guidelines for accuracy, precision, and stability.
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J Pharm Biomed Anal · Dec 1999
Stability, compatibility and plasticizer extraction of quinine injection added to infusion solutions and stored in polyvinyl chloride (PVC) containers.
The stability of quinine was determined in various diluents and in polyvinyl chloride (PVC) containers. The release of diethyhexyl phthalate (DEHP) from PVC bags into intravenous infusions of quinine was also measured. We used an injection of two doses of quinine; quiniforme at 500 mg and quinimax at 400 mg in either 250- or 500-ml PVC infusion bags containing 5% dextrose, to give initial nominal concentrations of 2 or 1 mg ml(-1) quiniforme and 1.6 or 0.8 mg ml(-1) quinimax, the mean concentrations commonly used in clinical practice. ⋯ The quantity was less than 2 microg ml(-1). During storage at 4 degrees C and room temperature the leaching of DEHP was low, but when the temperature was 45 degrees C the quantity was high, 21 microg ml(-1). To minimise patient exposure to DEHP, quinine solutions with all drugs should be infused immediately or stored for a maximum of 48 h at 4 degrees C.
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J Pharm Biomed Anal · Nov 1998
Stability study of fotemustine in PVC infusion bags and sets under various conditions using a stability-indicating high-performance liquid chromatographic assay.
The stability and compatibility of fotemustine, a nitrosourea anticancer agent, in 5% dextrose solution with polyvinyl chloride (PVC) containers and administration sets were studied under different conditions of temperature and light. The drug was diluted to 0.8 and 2 mg ml(-1) in 100 or 250 ml 5% dextrose injection solutions for 1-h simulated infusions using PVC bags and administration sets with protection from light. After preparation in the PVC bags containing 5% dextrose, fotemustine was also prepared at the same concentrations and stored at 4 degrees C for 48 h and at room temperature (22 degrees C) or at sunray exposure ( > 30 degrees C) over 8 h with or without protection from light. ⋯ There were no pH variation, no visual change, no color change, no visible precipitation and no loss of the drug. Conversely, when the solutions were exposed to light (ambient or solar), the drug concentration decreased rapidly, leading to the production of a degradation product as shown by mass spectral analysis and a discoloration of the solutions. Finally, in all cases, no DEHP (di-2-ethylhexyl phthalate) was detected in the injection solution.
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J Pharm Biomed Anal · Apr 1996
Stability and compatibility studies of zorubicin in intravenous fluids and PVC infusion bags.
The stability of zorubicin (ZOR) in admixtures for continuous intravenous infusion was studied. ZOR was reconstituted and diluted to 600 micrograms ml-1 for simulated infusion and to 250 and 1000 micrograms ml-1 for storage in poly(vinyl chloride) (PVC) bags containing 5% dextrose injection or 0.9% sodium chloride injection (0.9% NaCl). Bags were then stored at refrigerated temperature (4 degrees C) and in the dark for 24 h. ⋯ Changes in pH, particularly a decrease, seem to affect adversely the stability of ZOR. In fact, ZOR is rapidly converted into daunorubicin, the dominant degradation product, which is more cardiotoxic than the parent drug. Therefore, several precautions must be observed when the commercial product (Rubidazone) is prepared and reconstituted in i.v. fluids and containers.