Application of MEKC and UPLC with Fluorescence Detection for Simultaneous Determination of Amlodipine Besylate and Bisoprolol Fumarate. 2021

Sohila M Elonsy, and Fawzy A El Yazbi, and Rasha A Shaalan, and Hytham M Ahmed, and Tarek S Belal
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.

OBJECTIVE Two chromatographic methods were described for simultaneous determination of the antihypertensive drugs amlodipine besylate (AML) and bisoprolol fumarate (BIS). METHODS Method I applies micellar electrokinetic capillary chromatography using a deactivated fused silica capillary (25 cm effective length × 50 μm internal diameter). The background electrolyte consisted of 0.01 M borate buffer (pH 9.2) containing 0.025 M sodium dodecyl sulphate and methanol in the ratio of 80:20 (v/v). Valsartan (VAL) was used as an internal standard. Diode array detector was set at 238, 224, and 210 nm for measuring AML, BIS, and VAL, respectively. Method II involves using ultra-performance liquid chromatography with fluorescence detection. Zorbax SB-C8 column (2.1 × 100 mm, 1.8 μm particle size) was used with isocratic elution of the mobile phase composed of 0.1% trifluoroacetic acid, acetonitrile, and methanol in the ratio of 55:35:10 (v/v) at a flow rate of 0.6 mL/min. Fluorescence detection was done using excitation wavelengths 230 and 370 nm and emission wavelengths 305 and 450 nm for BIS and AML, respectively. Validation parameters were carefully studied including linearity, ranges, precision, accuracy, robustness, detection, and quantification limits. RESULTS Method I showed good linearity over the range 10-100 μg/mL for both dugs. Method II's linear ranges were 0.001-0.1 and 0.02-1 µg/mL for BIS and AML, respectively. CONCLUSIONS The proposed methods were successfully validated and applied for assay of the studied drugs in their fixed-dose combination tablets. CONCLUSIONS To the best of our knowledge, this study suggests the first electro-chromatographic and LC with fluorescence detection methods for simultaneous determination of amlodipine and bisoprolol.

UI MeSH Term Description Entries
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D000068756 Valsartan A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION. CGP 48933,Diovan,Kalpress,Miten,N-valeryl-N-((2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)valine,Nisis,Provas,Tareg,Vals,48933, CGP
D000959 Antihypertensive Agents Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. Anti-Hypertensive,Anti-Hypertensive Agent,Anti-Hypertensive Drug,Antihypertensive,Antihypertensive Agent,Antihypertensive Drug,Anti-Hypertensive Agents,Anti-Hypertensive Drugs,Anti-Hypertensives,Antihypertensive Drugs,Antihypertensives,Agent, Anti-Hypertensive,Agent, Antihypertensive,Agents, Anti-Hypertensive,Agents, Antihypertensive,Anti Hypertensive,Anti Hypertensive Agent,Anti Hypertensive Agents,Anti Hypertensive Drug,Anti Hypertensive Drugs,Anti Hypertensives,Drug, Anti-Hypertensive,Drug, Antihypertensive,Drugs, Anti-Hypertensive,Drugs, Antihypertensive
D017298 Bisoprolol A cardioselective beta-1 adrenergic blocker. It is effective in the management of HYPERTENSION and ANGINA PECTORIS. Bisoprolol Fumarate,Bisoprolol Fumarate (1:1) Salt, (+-)-Isomer,Bisoprolol Fumarate (2:1) Salt, (+-)-Isomer,Bisoprolol Hydrochloride,Bisoprolol Methanesulfonate Salt,Bisoprolol, (+-)-Isomer,Bisoprolol, (-)-Isomer,Bisoprolol, Fumarate (1:1) Salt,Bisoprolol, Fumarate (2:1) Salt,CL-297939,Concor,EMD-33512,CL 297939,CL297939,EMD 33512,EMD33512,Fumarate, Bisoprolol,Hydrochloride, Bisoprolol
D017311 Amlodipine A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION. Amlodipine Besylate,Amlodipine Maleate,Amlodipine Maleate (1:1),Amlodipine, (+-)-Isomer,Amlodipine, (+-)-Isomer, Maleate (1:1),Amlodipine, (R)-Isomer,Amlodipine, (S)-Isomer, Maleate (1:1),Amlodis,Amlor,Astudal,Istin,Norvasc
D020374 Chromatography, Micellar Electrokinetic Capillary A hybrid separation technique combining both chromatographic and electrophoretic separation principles. While the method was invented to separate neutral species, it can also be applied to charged molecules such as small peptides. MECC,MEKC,Micellar Electrokinetic Capillary Chromatography

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