An LC-MS/MS Method for Determination of Triple Drugs Combination of Valsartan, Amlodipine and Hydrochlorothiazide in Human Plasma for Bioequivalence Study

Said, Rana; Arafat, Basel; Arafat, Tawfiq; Mallah, Eyad

doi:10.2174/1573412916666191111125807

Cited by 4 publications

(1 citation statement)

References 53 publications

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“…The commonly used ionization technique in the development of bio analytical methods was Electron Spray Ionization (ESI) and Atmospheric Pressure Chemical Ionization (APCI) [70]. The sample preparation which was carried out by PP in tandem LC-MS is massively a parallel approach which was often employed in analysis of biological matrix [71]. Hyphenated techniques such as HPLC with UV and mass spectrometry has proven a beneficial conjunction with biological screening of pharmaceutical drugs [70].…”

Section: Hyphenated Techniquesmentioning

confidence: 99%

Bioanalytical methods and extraction techniques for the quantification of hydrochlorothiazide and its pharmaceutical combinations: A comprehensive review

Chakraborty,

Jayaseelan,

Rathinam

et al. 2024

AChrom

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Hydrochlorothiazide has been utilized clinically for the past half-century, which is popularly known as a “water pill” as it produces increased urine output. The advancement of bioanalytical methods brought a dynamic field with exciting opportunities for future research. The current review emphasis the bioanalytical methods employed for the quantitative estimation of Hydrochlorothiazide as monotherapy and its popularly used combinational medications available from 1956 to till date. A fixed dose of 25 mg of hydrochlorothiazide with 43 combinational medications is currently available in the market and these combinations are widely employed in the treatment of hypertensive people; those whose blood pressure does not respond effectively to monotherapy of hydrochlorothiazide and also for the treatment of edema (excess fluid in the body) caused by illness such as heart failure, liver problems, and renal disease. It has been convincingly demonstrated that the combination of any two antihypertensive medications belonging to different groups of the same category, significantly lowers blood pressure, in comparison with the effect produced by increasing the dose of a single medicament. Among the various analytical techniques employed for the estimation of Hydrochlorothiazide, the review portrays that hyphenated technique, in specific liquid chromatography coupled with mass spectroscopy was widely employed. The validation parameters namely linearity, LOD, LOQ for individual drug and their combinations, were successfully calibrated. The effectiveness of analytical approaches was evaluated and enhanced for chemical factors. The involvement of green chemistry in the optimized methods for the evaluation of Hydrochlorothiazide for the future development, are suggested.

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Section: Hyphenated Techniquesmentioning

confidence: 99%

Bioanalytical methods and extraction techniques for the quantification of hydrochlorothiazide and its pharmaceutical combinations: A comprehensive review

Chakraborty,

Jayaseelan,

Rathinam

et al. 2024

AChrom

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Sustainable chromatographic quantitation of multi-antihypertensive medications: application on diverse combinations containing hydrochlorothiazide along with LC–MS/MS profiling of potential impurities: greenness and whiteness evaluation

Marzouk,

El-Hanboushy,

Obaydo

et al. 2023

BMC Chemistry

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Cardiovascular disorders are among the leading causes of death worldwide, especially hypertension, a silent killer syndrome requiring multiple drug therapy for appropriate management. Hydrochlorothiazide is an extensively utilized thiazide diuretic that combines with several antihypertensive drugs for effective treatment of hypertension. In this study, sustainable, innovative and accurate high performance liquid chromatographic methods with diode array and tandem mass detectors (HPLC–DAD and LC–MS/MS) were developed, optimized and validated for the concurrent determination of Hydrochlorothiazide (HCT) along with five antihypertensive drugs, namely; Valsartan (VAL), Amlodipine besylate (AML), Atenolol (ATN), Amiloride hydrochloride (AMI), and Candesartan cilextil (CAN) in their diverse pharmaceutical dosage forms and in the presence of Chlorothiazide (CT) and Salamide (DSA) as HCT officially identified impurities. The HPLC–DAD separation was achieved utilizing Inertsil ODS-3 C18 column (250 × 4.6 mm, 5 μm) attached with photodiode array detection at 225.0 nm. Gradient elution was performed utilizing a mixture of solvent A (20.0 mM potassium dihydrogen phosphate, pH 3.0 ± 0.2, adjusted with phosphoric acid) and solvent B (acetonitrile) at ambient temperature. Linearity ranges were 0.1–100.0 µg/mL for HCT, VAL, AML and CAN, 0.05 –100.0 µg/mL for both ATN and AMI and 0.05–8.0 µg/mL for both CT and DSA. Additionally, this work describes the use of liquid chromatography–electrospray–tandem mass spectrometry for the accurate detection and quantification of the impurities; CT and DSA in the negative mode utilizing triple quadrupole mass spectrometry. The linearity ranges for those impurities were 1.0–200.0 ng/mL and 5.0–200.0 ng/mL for CT and DSA, respectively. Developed methods’ validation was achieved in accordance with International Conference on Harmonization (ICH) guidelines. Upon applying liquid chromatographic techniques for the drug analysis, a green and sustainable assessment have to be handled due to the consumption of energy and many solvents. Through the use of the HEXAGON, Analytical Greenness (AGREE) and White Analytical Chemistry (WAC) tools, greenness and sustainability have been statistically assessed. The optimized HPLC–DAD and LC–MS/MS methods were fast, accurate, precise, and sensitive, and consequently could be applied for conventional analysis and quality control of the proposed drugs in their miscellaneous dosage forms for the purpose of reducing laboratory wastes, time of the analysis time, effort, and cost. Graphical Abstract

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Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study

Gao

Zou

2022

CPA

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Background: Perampanel (PER) is a third-generation anti-epileptic drugs (AEDs). Several methods have been developed for the quantification of perampanel in plasma. The pharmacokinetic characteristics of perampanel in healthy Chinese Ssubjects have not been comprehensively reported. Objective: A simple, fast and sensitive LC-MS/MS method was established and validated for the quantification of perampanel in human plasma and its application to a bioequivalence study. Methods: Chromatographic separation was accomplished on a ZORBAX Eclipse XDB-Phenyl column (4.6 mm × 75 mm, 3.5 μm) using a binary gradient with mobile phase (A) (water containing 5 mmol/L ammonium acetate containing and 0.1% formic acid) and (B) (acetonitrile-water (95:5, v/v)) at a flow rate of 0.9 mL/min and sample preparation was by one-step protein precipitation via acetonitrile. Results: The total run time in this study was 4.5 min and the retention time of perampanel and perampanel-d5 (internal standard) were 2.30 min and 2.32 min, respectively. The method was developed and validated over the concentration range of 2.00-500 ng/mL for perampanel, with correlation coefficient greater than 0.9992. The inter-day precision was 3.1%-3.8% and accuracy 98.9%-103.5%. The intra-day precision was 2.4%-6.8% and accuracy 97.6%-104.9%. The extraction recovery ranged from 99.23%-103.84% and the matrix effect was not significant. Perampanel was proved to be stable in solution and human plasma under the different tested conditions. The validated method was successfully applied to a randomized, open-label, 2-period, crossover bioequivalence study in healthy Chinese subjects, and the results indicated that bioequivalence was achieved for 2 formulations of the 4-mg perampanel tablet under both fasting and fed conditions, and both treatments were safe and well tolerated by all study subjects. Conclusion: The validated method was successfully applied to a bioequivalence study of perampanel in human plasma and has achieved satisfactory results.

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An LC-MS/MS Method for Determination of Triple Drugs Combination of Valsartan, Amlodipine and Hydrochlorothiazide in Human Plasma for Bioequivalence Study

Cited by 4 publications

References 53 publications

Bioanalytical methods and extraction techniques for the quantification of hydrochlorothiazide and its pharmaceutical combinations: A comprehensive review

Bioanalytical methods and extraction techniques for the quantification of hydrochlorothiazide and its pharmaceutical combinations: A comprehensive review

Sustainable chromatographic quantitation of multi-antihypertensive medications: application on diverse combinations containing hydrochlorothiazide along with LC–MS/MS profiling of potential impurities: greenness and whiteness evaluation

Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study

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