Development, optimization and validation of a highly sensitive UPLC–ESI-MS/MS method for simultaneous quantification of amlodipine, benazeprile and benazeprilat in human plasma: Application to a bioequivalence study

Rezk, Mamdouh R.; Badr, Kamal A.

doi:10.1016/j.jpba.2014.05.005

Cited by 35 publications

(12 citation statements)

References 17 publications

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“…SF has a very rapid elimination half life compared with LD, as shown in Tables 5 and 6. Evaluation of truncated area for LD in the assessment of its bioequivalence was done [18,19]. Fig.…”

Section: Pharmacokinetic Evaluationmentioning

confidence: 99%

Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Rezk

Bendas

Basalious

et al. 2016

Journal of Chromatography B

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“…SF has a very rapid elimination half life compared with LD, as shown in Tables 5 and 6. Evaluation of truncated area for LD in the assessment of its bioequivalence was done [18,19]. Fig.…”

Section: Pharmacokinetic Evaluationmentioning

confidence: 99%

Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Rezk

Bendas

Basalious

et al. 2016

Journal of Chromatography B

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“…The optimized chromatographic conditions were achieved using acetonitrile–10 m m ammonium formate (pH 4.5) in a ratio of 70:30 ( v /v) at a flow rate of 0.25 mL/min. Increased lifetime of smaller columns and less solvent consumption together with a cleaner mass source owing to a smaller injection volume make this analytical method more attractive (De Nardi & Bonelli, ; Rezk & Badr, ). AML, ATO and IS peaks were eluted in a narrow range of retention times (0.62–0.68 min), which is advantageous for the compensation of matrix effects (Figure ).…”

Section: Resultsmentioning

confidence: 99%

Quantification of amlodipine and atorvastatin in human plasma by UPLC–MS/MS method and its application to a bioequivalence study

Rezk

Badr

2018

Biomedical Chromatography

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A robust, rapid and sensitive UPLC-MS/MS method has been developed, optimized and validated for the determination of amlodipine (AML) and atorvastatin (ATO) in human plasma using eplerenone as an internal standard (IS). Multiple-reaction monitoring in positive electrospray ionization mode was utilized in Xevo TQD LC-MS/MS. Double extraction was used in sample preparation using diethyl ether and ethyl acetate. The prepared samples were analyzed using an Acquity UPLC BEH C (50 × 2.1 mm, 1.7 μm) column. Ammonium formate and acetonitrile, pumped isocraticaly at a flow rate of 0.25 mL/min, were used as a mobile phase. Method validation was done as per the US Food and Drug Administration guidelines. Linearity was achieved in the range of 0.1-10 ng/mL for AML and 0.05-50 ng/mL for ATO. Intra-day and inter-day accuracy and precision were calculated and found to be within the acceptable range. A short run time, of <1.5 min, permits analysis of a large number of plasma samples per batch. The developed and validated method was applied to estimate AML and ATO in a bioequivalence study in healthy human volunteers.

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“…SF and IS are eluted in the narrow range of retention times (0.52–0.57 min), as shown in Fig. , which is advantageous for the compensation of matrix effects (Rezk and Badr, ). The reproducibility of retention times for the analytes, expressed as CV, was ≤0.67% for 100 injections on the same column.…”

Section: Resultsmentioning

confidence: 99%

Novel and sensitive UPLC–MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study

Rezk

Basalious

Amin³

2016

Biomedical Chromatography

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A novel and sensitive LC-MS/MS method was developed and validated for determination of sofosbuvir (SF) using eplerenone as an internal standard. The Xevo TQD LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. Extraction with tert-butyl methyl ether was used in sample preparation. The prepared samples were chromatographed on Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 μm) column by pumping 0.1% formic acid and acetonitrile in an isocratic mode at a flow rate of 0.35 mL/min. Method validation was performed as per the US Food and Drug Administration guidelines and the standard curves were found to be linear in the range of 0.25-3500 ng/mL for SF. The intra- and inter-day precision and accuracy results were within the acceptable limits. A very short run time of 1 min made it possible to analyze more than 500 human plasma samples per day. A very low quantification limit of SF allowed the applicability of the developed method for determination of SF in a bioequivalence study in human volunteers. Copyright © 2016 John Wiley & Sons, Ltd.

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Development, optimization and validation of a highly sensitive UPLC–ESI-MS/MS method for simultaneous quantification of amlodipine, benazeprile and benazeprilat in human plasma: Application to a bioequivalence study

Cited by 35 publications

References 17 publications

Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Quantification of amlodipine and atorvastatin in human plasma by UPLC–MS/MS method and its application to a bioequivalence study

Novel and sensitive UPLC–MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study

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