التحليل بالحقن التدفق الجرياني مع قياس التعكرية للتقدير الكمي لهيدروكلوريد الميفبيرين (MBH) في المستحضرات الصيدلانية
محتوى المقالة الرئيسي
الملخص
كان الهدف الرئيسي من هذه الورقة هو تطوير والتحقق من صحة طريقة حقن التدفق، وهي طريقة دقيقة ودقيقة وبسيطة واقتصادية ومنخفضة التكلفة ومحددة لقياس التعكر من أجل التقدير الكمي لهيدروكلوريد الميفبيرين (MBH) في المستحضرات الصيدلانية. تم أستخدام محلل NAG Dual & Solo محلي الصنع (0-180º درجة) والذي يحتوي على وحدتي اكتشاف متطابقتين (الخلية 1 و2) لقياسات التعكر. تم تحسين الطريقة المطورة من خلال اجراء معاييرات كيميائية وفيزيائية مختلفة مثل تركيزات الكاشف ومحاليل الأملاح المائية ومعدل التدفق وشدة ضوء المصدر وحجم العينة وملف الخلط ووقت الحقن. كانت معاملات الارتباط للطريقة المطورة(r) 0.9980 و0.9986 للخلية 1 و2 على التوالي وأظهرت استجابة خطية ضد التركيز على مدى 1.0 إلى 6.5 و 0.7-6.5 مليمول / لتر للخلية 1 و 2 على التوالي. كان حد الكشف (LOD) للخلية 1 والخلية2 هو 0.28 و0.21 مليمول / لتر على التوالي. أظهرت الدقة خلال اليوم وبين اليوم لتقديرين تسلسليين 3.5 و 5.5 مليمول / لتر من MBH انحرافًا معياريًا نسبيًا قدره 0.46٪ ، 0.28٪ ، 0.23٪ ، 0.26٪ و 0.39٪ ، 0.79٪ ، 0.14٪ ، 0.05 ٪ للخلية 1 و 2 على التوالي. تم التعبير عن دقة الطريقة المطورة كنسبة مئوية للاسترداد (Rec٪) ونسبة خطأ تتراوح بين 99.22 إلى 101.13 و 99.39 إلى 101.17 للخلية 1 والخلية 2 على التوالي. تم اتباع إرشادات ICH للتحقق من صحة الطريقة. تم تطبيق الطريقة التي تم تطويرها بنجاح لتحديد MbH في المستحضرات النقية والصيدلانية ويمكن استخدام الطريقة بشكل ملائم للتحليل الروتيني في المختبر كطريقة لمراقبة الجودة لأن الطريقة تسمح بالتحديد الكمي لـ 60 عينة / ساعة.
تفاصيل المقالة
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كيفية الاقتباس
المراجع
Sweetman SC. Martindale: The Complete Drug Reference. Drug Monographs. London: Pharmaceutical press; 2011.
Chakraborty DS, Hazra A, Sil A, Pain S. Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome. J Family Med Prim Care. 2019;8(10):3173-8.
Ivashkin VT, Yu AS, Ye KB, Ye AB, Beniashvili AG, Vasilyev SV, et al. Diagnosis and treatment of the irritable bowel syndrome: clinical guidelines of the Russian gastroenterological association and Russian association of coloproctology. J Gastroenterol Hepatol. 2018;27(5):76-93.
Abdulhady SS, Ibrahim KMH. Preparation and evaluation of mebeverine hydrochloride as mucoadhesive buccal tablet for local anesthesia. Trop J Pharm Res. 2017;16(8):1805.
Maev IV, Kucheravy YA, Tsukanov VV, Eremnia EY, Andreev DN, Abdulhakov SR, et al. Effectiveness of mebeverine in patients with post-cholecystectomy gastrointestinal spasm: results of prospective observational program "odyssey". TERAPEVT ARKH. 2018;90(8):40-7.
El Nabarawi MA, Teaima MH, Abd El-Monem RA, El Nabarawy NA, Gaber DA. Formulation, release characteristics, and bioavailability study of gastroretentive floating matrix tablet and floating raft system of Mebeverine HCl. Drug Des Devel Ther. 2017;11:1081-93.
Aronson JKMADMFHH. Mebeverine. Sixteenth Edition ed: Elsevier B.V; 2016. p. 779.
Cartwright AC. The British pharmacopoeia, 1864 to 2014: medicines, international standards and the state: Routledge; 2016.
Ibrahim H, Issa YM, Abu-Shawish HM. Improving the detection limits of antispasmodic drugs electrodes by using modified membrane sensors with inner solid contact. J Pharm Biomed Anal. 2007;44(1):8-15.
Derayea SMS. An application of eosin Y for the selective spectrophotometric and spectrofluorimetric determination of mebeverine hydrochloride. Anal Methods. 2014;6(7):2270-5.
Walash M, El-Din MS, El-Enany N, Eid M, Shalan S. First derivative synchronous fluorescence spectroscopy for the simultaneous determination of sulpiride and mebeverine hydrochloride in their combined tablets and application to real human plasma. J. Fluoresc. 2010;20(6):1275-85.
Mahdi A, Abas Z. Spectrophotometric Determination of Mebeverine hydrochloride in pharmaceutical preparation via Ion Association Reaction. JPhCS. 2018;1032(1):012064.
Lotfy HM, Fayez YM, Michael AM, Nessim CK. Simultaneous determination of mebeverine hydrochloride and chlordiazepoxide in their binary mixture using novel univariate spectrophotometric methods via different manipulation pathways. Spectrochim Acta A Mol Biomol Spectrosc. 2016;155:11-20.
Elmasry MS, Elazazy MS, Hassan WS. Utilization of Ion-Associate Formation in Spectroscopic and Conductometric Determination of Mebeverine Hydrochloride in Pharmaceutical Formulations. Int J Electrochem Sci. 2013;8:3888-901.
Othman AA, Bagary RI, Elkady EF, El-Kerdawy MM. Development and Validation of Spectrophotometric Methods for Simultaneous Determination of Mebeverine Hydrochloride and Chlordiazepoxide In Bulk and In Dosage Form. Pharm Anal Acta. 2006;7(8).
Siddappa K, Mallikarjun M, Reddy T, Tambe M. Simple and sensitive extractive spectrophotometeric method for the assay of Mebeverine Hydrochloride in pure and pharmaceutical formulations. J Chin Chem Soc. 2008;55(5):1062-8.
Aa O, Ri EB. Development and Validation of Spectrophotometric Methods for the Simultaneous Determination of Mebeverine Hydrochloride and Chlordiazepoxide in Bulk and in Dosage Form. Pharm Anal Acta. 2016;7(7).
Parag SM, Senthilkumar GP. Method Development and Validation of Mebeverine HCl in Bulk Drugs by Using Spectrophotometric Method. RJPT. 2016;9(9):1407.
Jeber Jalal N, Hassan Raed F, Hammood Mohammad K. Solid Phase Extraction of Theophylline in Aqueous Solutions by Modified Magnetic Iron Oxide Nanoparticles as an Extractor Material and Spectrophotometry Technique for the Determination. Res J Chem Environ. 2019;1(23): 94-100
El Walily AFM, El Gindy A, Bedair MF. Application of first-derivative UV-spectrophotometry, TLC-densitometry and liquid chromatography for the simultaneous determination of mebeverine hydrochloride and sulpiride. J Pharm Biomed. 1999;21(3):535-48.
Panda SS, Ravi Kumar Bera VV, Sahoo P, Sahu B. Quantitative estimation of mebeverine hydrochloride in sustained-release dosage form using an analytical lifecycle management oriented stability-indicating LC method. J LIQ Chromatogr R T. 2018;41(10):637-44.
Nezhadali A, Bonakdar GA. Multivariate optimization of mebeverine analysis using molecularly imprinted polymer electrochemical sensor based on silver nanoparticles. J Food Drug Anal. 2019;27(1):305-14.
Lakshmi MV, Pavani M, Rao GD. Rp-hplc method for determination of mebeverine hydrochloride in dosage forms employing ms compatible buffers. Indian Drug. 2020;57(3):69-72.
Kumar KRS, Meyyanathan SN, Gowramma B. Chiral RP-HPLC method for enantiomeric separation of mebeverine hydrochloride in the formulation. Indo Am J Pharm Res. 2015;5(8):2756-64.
Syed A, Rasheed SH, Afroz S, Noor SW, Fatima SS, Muzaffar-ur-Rehman MD. Development and Validation of Mebeverine Hydrochloride Assay by RP-HPLC Method. IJPSN. 2018;11(5):4239-43.
Elmasry MS, Blagbrough IS, Rowan MG, Saleh HM, Kheir AA, Rogers PJ. Quantitative HPLC analysis of mebeverine, mesalazine, sulphasalazine and dispersible aspirin stored in a Venalink monitored dosage system with co-prescribed medicines. J Pharm Biomed. 2011;54(4):646-52.
Haggag RS, Shaalan RA, Belal TS. Validated HPLC determination of the two fixed dose combinations (chlordiazepoxide hydrochloride and mebeverine hydrochloride; carvedilol and hydrochlorothiazide) in their tablets. J AOAC Int. 2010;93(4):1192-200.
Radwan MA, Abdine HH, Aboul‐Enein HY. A validated chiral HPLC method for the determination of mebeverine HCl enantiomers in pharmaceutical dosage forms and spiked rat plasma. Biomed Chromatogr. 2006;20(2):211-6.
Moskaleva NE, Baranov PA, Mesonzhnik NV, Appolonova SA. HPLC-MS/MS method for the simultaneous quantification of desmethylmebeverine acid, mebeverine acid and mebeverine alcohol in human plasma along with its application to a pharmacokinetics study. J Pharm Biomed. 2017;138:118-25.
Ibrahim H, Issa YM, Abu-Shawish HM. Potentiometric flow injection analysis of mebeverine hydrochloride in serum and urine. J Pharm Biomed. 2005;36(5):1053-61.
Salama NN, Zaazaa HE, Azab SM, Atty SA, El-Kosy NM, Salem MY. Utility of gold nanoparticles/silica modified electrode for rapid selective determination of mebeverine in micellar medium: comparative discussion and application in human serum. Ionics. 2016;22(6):957-66.
Hoogewijs G, Massart DL. Development of a standardized analysis strategy for basic drugs, using ion‐pair extraction and HPLC. Part 8. Method construction for the determination of mebeverine in tablets and biofluids. J Chromatogr. 1986;377:391-8.
Naguib IA, Abdelkawy M. Development and validation of stability indicating HPLC and HPTLC methods for determination of sulpiride and mebeverine hydrochloride in combination. Eur J Med Chem. 2010;45(9):3719-25.
Pinkston JD, Chester TL. Putting Opposites Guidelines for Successful SFC/MS. Anal Chem. 1995;67(21):650A-6A.
Srinivasan V, Sivaramakrishnan H, Karthikeyan B, Balaji TS, Vijayabaskar S. Stress degradation studies on mebeverine hydrochloride and development of a validated stability indicating UPLC method. J LIQ Chromatogr R T. 2011;34(16):1631-44.
Jeber, J.N. and Turkey, N.S. An optoelectronic flow-through detectors for active ingredients determination in the pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis. 2021; 201, p.114128.
Turkey, Nagham S., and Jalal N. Jeber.A flow analysis system integrating an optoelectronic detector for the quantitative determination of active ingredients in pharmaceutical formulations. Microchemical Journal. 202; 160 (2021): 105710.
University of Tanta Details Findings in Fullerenes (Carbon Nanotubes Modified Electrode for Enhanced Voltammetric Sensing of Mebeverine Hydrochloride in Formulations and Human Serum Samples). Nanotechnology Weekly. 2017:397.
Hu J, Stein A, Bühlmann P. Rational design of all-solid-state ion-selective electrodes and reference electrodes. TrAC. 2016;76:102-14.
Jeber JN. Quantitative Determination of Ephedrine Hydrochloride in Pharmaceutical Injections by Highly Sensitive Turbidimetric and Reversed-Phase Combined with UFLC Methods. Chem Chem Technol. 2019; 2(13):269-74.
Hammood MK, Jeber JN, Muhamad YH. Two Techniques (Spectrophotometric and Turbidimetric) for Determination of Ciprofloxacin HCl in Pharmaceutical Drugs with Comparison between the Techniques. IJS. 2016;57(3A):1620-8.
Guideline ICHHT. Validation of analytical procedures: text and methodology. Q2 (R1). 2005;1:1-15.
Pharmacopoeia B. Her Majesty’s Stationery Office. London 1988:A195—A200.
Miller J, Miller JC. Statistics and chemometrics for analytical chemistry: Pearson education; 2018.