Optimization for detection of flunarizine by high performance liquid chromatography/electrospray/mass spectrometry

Fuh, Ming‐Ren; Hsieh, Chi-Jen; Tai, Yu-Lun

doi:10.1016/s0039-9140(99)00072-7

Cited by 7 publications

(3 citation statements)

References 8 publications

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“…The present method is simpler and more time efficient, as there is no need for derivatization reactions, compared to the reported methods for determination of flunarizine. 16,17 This study involved 2 independent trials, including a fasting trial and a postprandial trial. The subjects were screened separately, and there was no crossover between the 24 subjects within the fasting group and the 44 subjects within the postprandial group.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of Flunarizine Hydrochloride After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects

Zhou²,

et al. 2021

Clinical Pharm in Drug Dev

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We designed a study to compare the newly developed 5-mg flunarizine hydrochloride capsules (test) to that of its marketed counterpart (5-mg; reference) among healthy adult Chinese volunteers. We performed an open-label, singlecenter study that consisted of 2 randomized, crossover trials, including a fasting trial and a fed trial. In each part of the study, the subjects were randomly assigned to either receive the test or reference products (5-mg flunarizine) in a 1:1 ratio. Subjects then received the alternative products, following a 14-day washout period. Concentrations of plasma flunarizine were analyzed using liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters (noncompartmental model) were evaluated using the WinNonlin software. The analysis of variance and Food and Drug Administration bioequivalence statistical criterion of 90% confidence interval for 80% to 125% range (set at P ≤ .05) of geometric means ratios of test: reference product for peak plasma concentration, area under the plasma concentrationtime curve (AUC) from time 0 to time t, and AUC from time 0 to infinity were determined. Tolerability was evaluated during the entire study period. Overall, 23 volunteers completed the fasting study, while 40 volunteers completed the fed study. The test formulation was found to be bioequivalent to the marketed formulation, as the 90% confidence interval for the ratio of geometric means of peak plasma concentration (fasting: 87.61%-101.67%; fed: 87.38%-104.06%), AUC from time 0 to time t (fasting: 89.44%-99.92%; fed: 92.65%-98.28%), and AUC from time 0 to infinity (fasting: 95.02%-104.33%; fed: 90.41%-96.96%) were within equivalence limits (80-125%) under both the fasting and fed conditions. When flunarizine was given alongside high-fat meals, time to maximum concentration was delayed ≈3.5 hours compared to fasting conditions. Meantime, high-fat meals increased its exposure by nearly 50%. Furthermore, there were no serious adverse events found among the subjects. This study confirmed that test and reference flunarizine hydrochloride capsules were bioequivalent under fasting and postprandial conditions.

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Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of Flunarizine Hydrochloride After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects

Zhou²,

et al. 2021

Clinical Pharm in Drug Dev

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“…There are a number of methods described in the literature discussing the use of spectrophotometric techniques for flunarizine determination [4] , [5] as well as other chromatographic methods such as GC [6] , [7] , [8] . There are also a range of other papers describing the HPLC analysis of the compound in a number of matrices [9] , [10] , [11] , [12] . The current work presents a method that reduces the analysis time for flunarizine and its related impurities by almost 60% in comparison to the current approved European Pharmacopoeia method while still meeting the requirements for the validation parameters tested.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a rapid chromatographic method for the analysis of flunarizine and its main production impurities

O'Connor

Geary

Wharton

et al. 2013

Journal of Pharmaceutical Analysis

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A rapid selective method for the analysis of flunarizine and its associated impurities was developed and validated according to ICH guidelines. The separation was carried out using a Thermo Scientific Hypersil Gold C18 column (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of acetonitrile–ammonium acetate–tetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8 mL/min and UV detection at 230 nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented.

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“…Several chromatographic procedures for determination of flunarizine dihydrochloride have been described such as gas chromatography (GC) [8][9][10][11], high performance liquid chromatography (HPLC) [12][13][14][15][16][17] and high performance liquid chromatography interfaced with electrospray mass spectrometry (HPLC-ES-MS) [18,19]. These methods have been mainly used for the analysis of flunarizine and its metabolites in biological fluids.…”

Section: Introductionmentioning

confidence: 99%

Comparison of UV spectrophotometric method and high performance liquid chromatography for the analysis of flunarizine and its application for the dissolution test

Busaranon¹,

Suntornsuk²,

Suntornsuk³

2006

Journal of Pharmaceutical and Biomedical Analysis

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Optimization for detection of flunarizine by high performance liquid chromatography/electrospray/mass spectrometry

Cited by 7 publications

References 8 publications

Pharmacokinetics of Flunarizine Hydrochloride After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects

Pharmacokinetics of Flunarizine Hydrochloride After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects

Development and validation of a rapid chromatographic method for the analysis of flunarizine and its main production impurities

Comparison of UV spectrophotometric method and high performance liquid chromatography for the analysis of flunarizine and its application for the dissolution test

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