طريقة HPLC لتقدير كمية Zonisamide في البلازما البشرية المسننة
DOI:
https://doi.org/10.35516/jjps.v15i1.288الكلمات المفتاحية:
التحقق من صحة الطريقة التحليلية، HPLC، ارتفعت البلازما البشرية، الانحدار الخطي المرجح، Zonisamideالملخص
في العمل الحالي ، تم تطوير طريقة HPLC بسيطة ودقيقة ودقيقة مع الكشف عن الأشعة فوق البنفسجية من أجل قياس كمية zonisamide (ZON) في البلازما البشرية المسننة باستخدام تريميثوبريم (TRI) كمعيار داخلي. تم فصل كل من ZON و TRI جيدًا وحلهما عن بعضهما البعض في عمود C18 باستخدام مزيج الطور المتحرك للميثانول: acetonitrile: 20 mM phosphate buffer (pH 3.0) في الوضع الأيزوقي بمعدل تدفق 1 مل / دقيقة بنسبة 25: 5 : 70٪ ، حجم / حجم / حجم. تم الحصول على أقصى قدر من استعادة ZON و TRI من البلازما باستخدام ثنائي كلورو ميثان (DCM) كمستخلص مذيب. تم العثور على منحنى المعايرة ليكون خطي في نطاق 3-60 ميكروغرام / مل مع معامل الانحدار (r2) = 0.997. على الرغم من أن r2 مقبول ، لوحظ مرونة غير متجانسة لبيانات المعايرة والتي تم تقليلها أيضًا باستخدام الانحدار الخطي الموزون مع عامل الترجيح 1 / x. أخيرًا ، تم التحقق من صحة الطريقة فيما يتعلق بالحساسية ، والدقة ، والدقة ، والاستعادة ، والاستقرار ، والترحيل وفقًا لتوجيهات إدارة الأغذية والعقاقير الأمريكية للتحقق من صحة الطريقة التحليلية الحيوية ، مايو 2018.
المراجع
Indian Pharmacopoeia. Ministry of Health and Family Welfare; 2018, p 3555.
Leppik I. E. Zonisamide: chemistry, mechanism of action, and pharmacokinetics. Seizure. 2004;13:S5–9.
Shimoyama R., Ohkubo T. and Sugawara K. Monitoring of zonisamide in human breast milk and maternal plasma by solid-phase extraction HPLC method. Biomed Chromatogr. 1999;13(5):370–372.
Majnooni M. B., Mohammadi B., Jalili R. and Bahrami G. H. Rapid and sensitive high performance liquid chromatographic determination of zonisamide in human serum application to a pharmacokinetic study. Indian J Pharm Sci. 2012;74(4):360–364.
Yeniceli D. Development and validation of a simple and efficient HPLC method for the determination of zonisamide in pharmaceuticals and human plasma. J Anal Chem. 2013;68(5):436–443.
Lourenço D., Sarraguça M., Alves G., Coutinho P., Araujo A. R. T. S. and Rodrigues M. A novel HPLC method for the determination of zonisamide in human plasma using microextraction by packed sorbent optimised by experimental design. Anal Methods. 2017;9(40):5910–5919.
Juenke J. M., Brown P. I., Urry F. M. and McMillin G. A. Drug monitoring and toxicology: A procedure for the monitoring of levetiracetam and zonisamide by HPLC-UV. J Anal Toxicol. 2006;30(1):27–30.
Griner-Sosanko E., Lower D. R., Virji M. A. and Krasowski M. D. Simultaneous determination of lamotrigine, zonisamide and carbamazepine in human plasma by high-performance liquid chromatography. Biomed Chromatogr. 2007;21(3):225–228.
Gonçalves J., Alves G., Bicker J., Falcão A. and Fortuna A. Development and full validation of an innovative HPLC-diode array detection technique to simultaneously quantify lacosamide, levetiracetam and zonisamide in human plasma. Bioanalysis. 2018;10(8):541–557.
Vermeij T. A. C. and Edelbroek P. M. Robust isocratic high performance liquid chromatographic method for simultaneous determination of seven antiepileptic drugs including lamotrigine, oxcarbazepine and zonisamide in serum after solid-phase extraction. J Chromatogr B Anal Technol Biomed Life Sci. 2007;857(1):40–46.
Ma C-L., Jiao Z. and Shi X-J. Simultaneous separation and determination of zonisamide, phenytoin carbamazepine and carbamazepine 10, 11-epoxide in human plasma using isocratic reversed-phase HPLC. Fudan Univ J Med Sci. 2007;34(4):603–607.
Ma C-L., Jiao Z., Jie Y. and Shi X-J. Isocratic reversed-phase HPLC for simultaneous separation and determination of seven antiepileptic drugs and two of their active metabolites in human plasma. Chromatographia. 2007;65(5–6):267–275.
Contin M., Mohamed S., Candela C., Albani F., Riva R. and Baruzzi A. Simultaneous HPLC-UV analysis of rufinamide, zonisamide, lamotrigine, oxcarbazepine monohydroxy derivative and felbamate in deproteinized plasma of patients with epilepsy. J Chromatogr B Anal Technol Biomed Life Sci. 2010;878(3–4):461–465.
Heideloff C., Bunch D. R. and Wang S. A novel HPLC method for quantification of 10 antiepileptic drugs or metabolites in serum/plasma using a monolithic column. Ther Drug Monit. 2010;32(1):102–106.
Baldelli S., Cattaneo D., Giodini L., Baietto L., Di Perri G., D’Avolio A. and Emilio C. Development and validation of a HPLC-UV method for the quantification of antiepileptic drugs in dried plasma spots. Clin Chem Lab Med. 2015;53(3):435–444.
Antonilli L., Brusadin V., Filipponi F., Guglielmi R. and Nencini P. Development and validation of an analytical method based on high performance thin layer chromatography for the simultaneous determination of lamotrigine, zonisamide and levetiracetam in human plasma. J Pharm Biomed Anal. 2011;56(4):763–770.
Matar K. M. A simple and accurate liquid chromatography-tandem mass spectrometry method for quantification of zonisamide in plasma and its application to a pharmacokinetic study. J Chromatogr B Anal Technol Biomed Life Sci. 2014;961:103–109.
Subramanian M., Birnbaum A. K. and Remmel R. P. High-speed simultaneous determination of nine antiepileptic drugs using liquid chromatography-mass spectrometry. Ther Drug Monit. 2008;30(3):347–356.
Deeb S., McKeown D. A., Torrance H. J., Wylie F. M., Logan B. K. and Scott K. S. Simultaneous analysis of 22 antiepileptic drugs in postmortem blood, serum and plasma using LC-MS-MS with a focus on their role in forensic cases. J Anal Toxicol. 2014;38(8):485–494.
Palte M. J., Basu S. S., Dahlin J. L., Gencheva R., Mason D., Jarolim P. and Petrides A. K. Development and validation of an ultra-performance liquid chromatography-tandem mass spectrometry method for the concurrent measurement of gabapentin, lamotrigine, levetiracetam, monohydroxy derivative of oxcarbazepine, and zonisamide concentrations in serum. Their Drug Monit. 2018;40(4):469–476.
D’urso A., Cangemi G., Barco S., Striano P., D’avolio A. and De Grazia U. LC-MS/MS-Based Quantification of 9 Antiepileptic Drugs From a Dried Sample Spot Device. Ther Drug Monit. 2019;41(3):331–339.
Tiwari G. and Tiwari R. Bioanalytical method validation: An updated review. Pharm Methods. 2010;1(1):25–38.
Andrade-Eiroa A, Canle M, Leroy-Cancellieri V, Cerdà V. Solid-phase extraction of organic compounds: A critical review. part II. TrAC Trends Anal Chem. 2016;80:655–667.
Prabu S. L. and Suriyaprakash T. N. K.: In: Applied Biological Engineering - Principles and Practice. BoD–Books on Demand; Naik G. R. (Ed).; IntechOpen, 2012; Chapter 21, pp 479–506.
Almeida A. M., Castel-Branco M. M. and Falcão A. C. Linear regression for calibration lines revisited: Weighting schemes for bioanalytical methods. J Chromatogr B Anal Technol Biomed Life Sci. 2002;774(2):215–222.
US-FDA. Bioanalytical Method Validation Guidance for Industry, May 2018 Available from: https://www.fda.gov/media/70858/download.
Moffat A. C., Osselton M. D., Widdop B. and Watts J. Clarke’s analysis of drugs and poisons. Vol. 3 ; Pharmaceutical press London. 2011, p 1717.
