Daniel Gonzalez, Chiara Melloni1, Brenda B Poindexter2, Ram Yogev, Andrew M Atz3, Janice E Sullivan4, Susan R Mendley5, Paula Delmore6, Amy Delinsky7, Kanecia Zimmerman1, Andrew Lewandowski8, Barrie Harper1, Kenneth C Lewis7, Daniel K Benjamin1,9, Michael Cohen-Wolkowiez1,9. 1. 2Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA. 2. 3Department of Pediatrics, Riley Hospital for Children, Indiana University, Indianapolis, IN, USA. 3. 5Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA. 4. 6Kosair Charities Pediatric Clinical Research Unit, Department of Pediatrics, University of Louisville, Kosair Children's Hospital, Louisville, KY, USA. 5. 7Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, USA. 6. 8Department of Neonatology, Wesley Medical Center, Wichita, KS, USA. 7. 9OpAns, LLC, 4134 S Alston Ave # 101, Durham, NC 27713, USA. 8. 10EMMES Corp., 401 N Washington St # 700, Rockville, MD 20850, USA. 9. 11Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.
Abstract
BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMX) is an antimicrobial drug combination commonly prescribed in children and adults. The study objectives were to validate and apply an HPLC-MS/MS method to quantify TMP-SMX in dried plasma spots (DPS) and dried urine spots (DUS), and perform a comparability analysis with liquid matrices. RESULTS: For TMP the validated range was 100-50,000 ng/ml for DPS and 500-250,000 ng/ml for DUS; for SMX, the validated range was 1000-500,000 ng/ml for both DPS and DUS. Good agreement was noted between DPS/DUS and liquid plasma and urine samples for TMP, while only modest agreement was observed for SMX in both matrices. CONCLUSION: A precise, accurate and reproducible method was developed to quantify TMP-SMX in DPS and DUS samples.
BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMX) is an antimicrobial drug combination commonly prescribed in children and adults. The study objectives were to validate and apply an HPLC-MS/MS method to quantify TMP-SMX in dried plasma spots (DPS) and dried urine spots (DUS), and perform a comparability analysis with liquid matrices. RESULTS: For TMP the validated range was 100-50,000 ng/ml for DPS and 500-250,000 ng/ml for DUS; for SMX, the validated range was 1000-500,000 ng/ml for both DPS and DUS. Good agreement was noted between DPS/DUS and liquid plasma and urine samples for TMP, while only modest agreement was observed for SMX in both matrices. CONCLUSION: A precise, accurate and reproducible method was developed to quantify TMP-SMX in DPS and DUS samples.
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