Quantitation of dextran 70 in peritoneal dialysate from patients administered 7.5% polyglucose |
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| Institution: | 166121. Baxter Healthcare, Renal Division MPR-R2, 1620 Waukegan Road, McGaw Park, IL 60085, USA;1. Department of Biomedical and Neuromotor Sciences, Section of Oral Sciences, University of Bologna, Bologna, Italy;2. Department of Surgery and Medical-Surgical Specialities, School of Medicine and Health Sciences, University of Oviedo, Oviedo, Spain;3. Oral and Maxillofacial Surgery Unit, IRCCS Azienda Ospedaliero-Universitaria, Bologna, Italy;4. Department of Biomedical and Neuromotor Sciences, Section of Maxillofacial Surgery at Policlinico S. Orsola-Malpighi, University of Bologna, Bologna, Italy;5. Functional and Molecular Neuroimaging Unit, Bellaria Hospital, Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy;6. IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy;7. Unit of Anatomic Pathology, S. Orsola Hospital, IRCCS Azienda Ospedaliero-Universitaria, Bologna, Italy;8. Department of Biomedical and Neuromotor Sciences, Section of Anatomic Pathology at Bellaria Hospital, University of Bologna, Bologna, Italy;1. University of Eastern Finland, School of Pharmacy, Yliopistonranta 1, 70210 Kuopio, Finland;2. Pharmaron, 7901 Vickers Street, San Diego, CA 92111, USA;3. 436 Creamery Way, Exton, PA, USA;4. University of Helsinki, Faculty of Pharmacy, Viikinkaari 5 E, 00790 Helsinki, Finland;5. Biostudy Solutions, LLC, 4008 Caesar Court, Wilmington, NC 28405, USA;6. Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA;7. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA |
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| Abstract: | A method using gel permeation chromatography was evaluated for the quantitation of dextran 70 in dialysate samples containing polyglucose. Dialysate samples containing dextran 70 and polyglucose were pretreated using the enzyme α-amylase to selectively hydrolyze the α(1–4)-linked polyglucose, while leaving the α(1–6)-linked dextran 70 intact. Following sample deproteinization with trichloroacetic acid, dextran 70 was quantitated using gel permeation chromatography with refractive index detection. This method was evaluated for accuracy, precision, specificity, linearity, range, and analyte stability. Adequate method linearity with a correlation of >0.999 was established over the range of dextran 70 concentration from 1 to 0.025 mg/ml. Method precision was approximately 2% R.S.D. and accuracy (% recovery) was approximately 98–100% in the typical sample concentration range (1–0.5 mg/ml). This method was applied to the determination of intraperitoneal fluid kinetics in continuous ambulatory peritoneal dialysis (CAPD) patients administered daily night-time intraperitoneal exchanges with either 7.5% polyglucose or 4.25% dextrose. Dextran 70 was added to the dialysis solutions to yield an initial concentration of 1 mg/ml. Dialysate samples were collected at various times over a 10-h dwell-time and assayed for dextran 70. Intraperitoneal volume profiles based on dextran 70 concentrations and drain volumes were then calculated for each dialysis solution. |
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