Sjoerd D Meenks, Anne J A Drost-Wijnne, Ralph A C van Wezel, Hans J A van Suijlekom, Willemijn Jansen, Arne A L Rutgers, Mieke W de Blois, Maarten J Deenen
{"title":"用于无菌腹腔神经丛阻滞的肠外制剂中苯酚和碘美醇同时定量的 UPLC-PDA 方法的验证及其在药物稳定性研究中的应用。","authors":"Sjoerd D Meenks, Anne J A Drost-Wijnne, Ralph A C van Wezel, Hans J A van Suijlekom, Willemijn Jansen, Arne A L Rutgers, Mieke W de Blois, Maarten J Deenen","doi":"10.1177/00185787241289023","DOIUrl":null,"url":null,"abstract":"<p><p><b>Objectives:</b> A commonly applied analgesic therapy for patients with severe abdominal pain due to cancer-related pain in the upper abdomen, is coeliac plexus neurolysis (CPN). Herein, a combination product of phenol and an iodine contrast agent are injected simultaneously. The chemical stability of such a combination product is unknown, and no chromatographic method is yet available that describes the simultaneous quantification of phenol and iomeprol. The aim of this study was to develop and validate a stability-indicating UPLC method for the simultaneous quantification of both phenol and iomeprol and to determine the chemical stability of a sterile 100 mg/mL phenol in 350 mg I/mL iomeprol solution for injection during shelf life. <b>Methods:</b> The product was compounded and sterilized in a GMP certified facility. The pharmaceutical analysis was validated by determination of the accuracy, precision, specificity, selectivity, carry-over and linearity. Pharmaceutical product stability was determined before and after sterilization, and during shelf life of 36 months at 25°C ± 2°C. <b>Results:</b> The accuracy for phenol and iomeprol was 97.1% to 99.3% and 100.0% to 100.2%, respectively. The RSD for repeatability and reproducibility for phenol were 0.65% and 1.17%, and for iomeprol 0.61% and 1.49%, respectively. All other tested parameters met the predefined validation criteria. All concentrations at all tested time points remained within ±2% of the initial concentrations for phenol and ±4% for iomeprol. No additional peaks were visible on the chromatograms. <b>Conclusion:</b> A stability-indicating method for the simultaneous quantification of phenol and iomeprol in a parental pharmaceutical preparation was developed and validated. This method was used to demonstrate the chemical stability of a newly developed sterile solution of 100 mg/mL phenol and 350 mg I/mL iomeprol. Chemical product stability was demonstrated during shelf life of up to 36 months.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":" ","pages":"00185787241289023"},"PeriodicalIF":0.8000,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559753/pdf/","citationCount":"0","resultStr":"{\"title\":\"Validation of an UPLC-PDA Method for the Simultaneous Quantification of Phenol and Iomeprol in a Sterile Parenteral Preparation Used for Coeliac Plexus Block, and Its Application to a Pharmaceutical Stability Study.\",\"authors\":\"Sjoerd D Meenks, Anne J A Drost-Wijnne, Ralph A C van Wezel, Hans J A van Suijlekom, Willemijn Jansen, Arne A L Rutgers, Mieke W de Blois, Maarten J Deenen\",\"doi\":\"10.1177/00185787241289023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Objectives:</b> A commonly applied analgesic therapy for patients with severe abdominal pain due to cancer-related pain in the upper abdomen, is coeliac plexus neurolysis (CPN). Herein, a combination product of phenol and an iodine contrast agent are injected simultaneously. The chemical stability of such a combination product is unknown, and no chromatographic method is yet available that describes the simultaneous quantification of phenol and iomeprol. The aim of this study was to develop and validate a stability-indicating UPLC method for the simultaneous quantification of both phenol and iomeprol and to determine the chemical stability of a sterile 100 mg/mL phenol in 350 mg I/mL iomeprol solution for injection during shelf life. <b>Methods:</b> The product was compounded and sterilized in a GMP certified facility. The pharmaceutical analysis was validated by determination of the accuracy, precision, specificity, selectivity, carry-over and linearity. Pharmaceutical product stability was determined before and after sterilization, and during shelf life of 36 months at 25°C ± 2°C. <b>Results:</b> The accuracy for phenol and iomeprol was 97.1% to 99.3% and 100.0% to 100.2%, respectively. The RSD for repeatability and reproducibility for phenol were 0.65% and 1.17%, and for iomeprol 0.61% and 1.49%, respectively. All other tested parameters met the predefined validation criteria. All concentrations at all tested time points remained within ±2% of the initial concentrations for phenol and ±4% for iomeprol. No additional peaks were visible on the chromatograms. <b>Conclusion:</b> A stability-indicating method for the simultaneous quantification of phenol and iomeprol in a parental pharmaceutical preparation was developed and validated. This method was used to demonstrate the chemical stability of a newly developed sterile solution of 100 mg/mL phenol and 350 mg I/mL iomeprol. Chemical product stability was demonstrated during shelf life of up to 36 months.</p>\",\"PeriodicalId\":13002,\"journal\":{\"name\":\"Hospital Pharmacy\",\"volume\":\" \",\"pages\":\"00185787241289023\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2024-10-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559753/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Hospital Pharmacy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/00185787241289023\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hospital Pharmacy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/00185787241289023","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Validation of an UPLC-PDA Method for the Simultaneous Quantification of Phenol and Iomeprol in a Sterile Parenteral Preparation Used for Coeliac Plexus Block, and Its Application to a Pharmaceutical Stability Study.
Objectives: A commonly applied analgesic therapy for patients with severe abdominal pain due to cancer-related pain in the upper abdomen, is coeliac plexus neurolysis (CPN). Herein, a combination product of phenol and an iodine contrast agent are injected simultaneously. The chemical stability of such a combination product is unknown, and no chromatographic method is yet available that describes the simultaneous quantification of phenol and iomeprol. The aim of this study was to develop and validate a stability-indicating UPLC method for the simultaneous quantification of both phenol and iomeprol and to determine the chemical stability of a sterile 100 mg/mL phenol in 350 mg I/mL iomeprol solution for injection during shelf life. Methods: The product was compounded and sterilized in a GMP certified facility. The pharmaceutical analysis was validated by determination of the accuracy, precision, specificity, selectivity, carry-over and linearity. Pharmaceutical product stability was determined before and after sterilization, and during shelf life of 36 months at 25°C ± 2°C. Results: The accuracy for phenol and iomeprol was 97.1% to 99.3% and 100.0% to 100.2%, respectively. The RSD for repeatability and reproducibility for phenol were 0.65% and 1.17%, and for iomeprol 0.61% and 1.49%, respectively. All other tested parameters met the predefined validation criteria. All concentrations at all tested time points remained within ±2% of the initial concentrations for phenol and ±4% for iomeprol. No additional peaks were visible on the chromatograms. Conclusion: A stability-indicating method for the simultaneous quantification of phenol and iomeprol in a parental pharmaceutical preparation was developed and validated. This method was used to demonstrate the chemical stability of a newly developed sterile solution of 100 mg/mL phenol and 350 mg I/mL iomeprol. Chemical product stability was demonstrated during shelf life of up to 36 months.
期刊介绍:
Hospital Pharmacy is a monthly peer-reviewed journal that is read by pharmacists and other providers practicing in the inpatient and outpatient setting within hospitals, long-term care facilities, home care, and other health-system settings The Hospital Pharmacy Assistant Editor, Michael R. Cohen, RPh, MS, DSc, FASHP, is author of a Medication Error Report Analysis and founder of The Institute for Safe Medication Practices (ISMP), a nonprofit organization that provides education about adverse drug events and their prevention.