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。

IF 0.8 Q4 PHARMACOLOGY & PHARMACY
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
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引用次数: 0

摘要

目的:腹腔神经丛神经溶解术(CPN)是治疗上腹部癌症相关性剧烈腹痛患者的常用镇痛疗法。在这种疗法中,需要同时注射苯酚和碘造影剂。这种混合产物的化学稳定性尚不清楚,也没有色谱法可同时定量分析苯酚和碘甲醇。本研究旨在开发并验证一种同时定量苯酚和碘美醇的稳定性指示 UPLC 方法,并确定注射用 350 毫克 I/ 毫升碘美醇溶液中 100 毫克/毫升无菌苯酚在保质期内的化学稳定性。方法产品在通过 GMP 认证的工厂进行配制和灭菌。通过测定准确度、精密度、特异性、选择性、携带性和线性,对药物分析进行了验证。测定了灭菌前后以及在 25°C ± 2°C 下 36 个月保质期内药品的稳定性。结果表明苯酚和碘甲醇的准确度分别为 97.1%至 99.3%和 100.0%至 100.2%。苯酚的重复性和再现性 RSD 分别为 0.65% 和 1.17%,碘甲醇的 RSD 分别为 0.61% 和 1.49%。所有其他测试参数均符合预定的验证标准。在所有测试时间点,苯酚和碘甲醇的浓度均保持在初始浓度的 ±2% 和 ±4% 范围内。色谱图上没有出现额外的峰值。结论建立并验证了同时定量母体药物制剂中苯酚和碘美醇的稳定性指示方法。该方法用于验证新开发的 100 mg/mL 苯酚和 350 mg I/mL 碘美醇无菌溶液的化学稳定性。结果表明,产品在长达 36 个月的保质期内具有化学稳定性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.

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来源期刊
Hospital Pharmacy
Hospital Pharmacy PHARMACOLOGY & PHARMACY-
CiteScore
1.70
自引率
0.00%
发文量
63
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.
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