Selective and rapid liquid chromatography-mass spectrometry method for the determination of lercanidipine in human plasma

Salem, Isam Ismail; Idrees, Jafer; Tamimi, Jaafar I Al; Farina, P.

doi:10.1016/j.jchromb.2003.12.019

Cited by 27 publications

(22 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It is reported that analytes of the lercanidipine, benazepril and benazeprilat were identified by HPLC [9][10][11][12]2,13,14], derivative spectrophotometry [15][16][17][18][19], capillary electrophoresis (CE) [20], high performance thin layer chromatography (HPTLC) [21], gas chromatography-mass spectrometry [22] and liquid chromatography-mass spectrometry [1,20,23]. Few methods are reported for the assay of combination drug products containing two or more active drug substances [12].…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of lercanidipine, benazepril and benazeprilat in plasma by LC–MS/MS and its application to a toxicokinetics study

Chen¹,

Zhang

Liu³

et al. 2012

Journal of Chromatography B

View full text Add to dashboard Cite

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of lercanidipine, benazepril and benazeprilat in plasma by LC–MS/MS and its application to a toxicokinetics study

Chen¹,

Zhang

Liu³

et al. 2012

Journal of Chromatography B

View full text Add to dashboard Cite

“…Increasing tG often increases the overall resolution of complex samples. For efficient gradient optimization the use of software simulation programs is very useful, since the predictions on the effects of gradient factors are not always intuitive [16].…”

Section: Phase 2-methods Optimizationmentioning

confidence: 99%

Application of Quality by Design for Development and Validation of RP-HPLC Method for Lercanidipine Hydrochloride

Bonde¹,

Bonde²,

Gawad³

2017

Asian J. Chem.

View full text Add to dashboard Cite

Current research deals with the development of accurate, precise and robust analytical liquid chromatographic method for lercanidipine hydrochloride by application of quality by design (QbD). The key objective of research was to monitor the factors affecting the quality of analysis and also to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Basic process parameters which have the most impact on method performance were defined as proportion of acetonitrile in the mobile phase, pH of the aqueous phase and the flow rate. Quality by design (QbD) approach provided quantitative process knowledge which can be used to identify the HPLC instrument parameter settings that provided optimum chromatographic performance. The method optimization was accomplished using Fusion AE TM software (SMatrix Corporation, Eureka, CA) in 2 phases. In Phase 1, rapid screening was done to reduce the number of independent variables followed by phase II where the method was optimized using a DOE approach. Response surface design was implemented for experimental robustness testing and the method is validated to verify the adequacy of selected ideal chromatographic conditions: the analytical column of phenomenex C18 (250 mm × 4.6 mm, 5 µm particle size), mobile phase consist of acetonitrile-aqueous phase (10 mM phosphate buffer, pH adjusted to 4.5, (Gradient, organic phase 82 to 95 % v/v), pump flow rate 1.2 mL/min, and wavelength of detection 236 nm. The quality by design (QbD) based method development helped in better understanding of the overall method capabilities and limitations and ensured a greater chance of effective method validation.

show abstract

“…There are a couple of commonly used ways of measuring matrix effects. One approach is to compare the MS response of the analyte spiked postextraction with that in a neat solution [124][125][126][127][128][129]. Since there is no extraction involved, any signal loss or enhancement in the post-extraction spiked sample will be assumed due to matrix effects.…”

Section: Matrix Effects and Recoverymentioning

confidence: 99%

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

Zhou¹,

Song²,

Tang³

et al. 2005

CPA

View full text Add to dashboard Cite

Swift growth in the use of LC-MS/MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high-quality data at many stages in drug discovery and development process: from high throughput screening of drug candidates and rapid data generation for pre-clinical studies to almost 'real-time' analysis of clinical samples. Prompt and rational method development, validation, and transfer play a pivotal role in achieving the goals of "faster, better, and cheaper" for pharmacokinetic studies since this could easily account for more than 50% of the time and labor resources for a moderate-sized project. Strategy for rational method development, validation and transfer has been largely kept as institutional knowledge but rarely appeared in literature. In this review article, strategies for developing and validating robust high throughput LC-MS/MS methods will be critically reviewed and discussed. Automated sample preparation, fast chromatography, minimization of matrix effects, and strategy of narrowing the gap between validation and incurred sample analysis are just a few topics covered in this review. Other interesting approaches for improving method efficiency and ruggedness such as direct injection SPE and liquid/liquid extracts as well as multiplexing of LC columns will also be discussed. Potential pitfalls during method development and validation are pointed out. At the end, the question "how fast is fast enough and how fast is too fast?" will be answered after considering all aspects of the method development and validation.

show abstract

Selective and rapid liquid chromatography-mass spectrometry method for the determination of lercanidipine in human plasma

Cited by 27 publications

References 5 publications

Simultaneous determination of lercanidipine, benazepril and benazeprilat in plasma by LC–MS/MS and its application to a toxicokinetics study

Simultaneous determination of lercanidipine, benazepril and benazeprilat in plasma by LC–MS/MS and its application to a toxicokinetics study

Application of Quality by Design for Development and Validation of RP-HPLC Method for Lercanidipine Hydrochloride

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

Contact Info

Product

Resources

About