High Performance Liquid Chromatographic Method for the Determination of Duloxetine and Desmethyl Duloxetine in Human Plasma

Johnson, James T.; Oldham, Samuel W.; Lantz, R.J.; DeLong, Allyn F.

doi:10.1080/10826079608005497

Cited by 26 publications

(20 citation statements)

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“…Plasma was assayed for duloxetine using a validated HPLC with fluorescence detection method over the linear concentration range of 1 ng ml -1 to 100 ng ml -1 (Covance Labs, Madison, WI, USA) in Study 2A] and using the previously described HPLC/MS/MS method in Study 2B. The HPLC/fluorescence assay is a modification of the HPLC/fluorescence assay published by Johnson et al [9]. Duloxetine and the internal standard (analogue of duloxetine) were extracted from alkaline plasma with methylene chloride and the extracted analytes were derivatized with dansyl chloride prior to injection onto a C18 HPLC column.…”

Section: Studies 2a and 2bmentioning

confidence: 99%

Effect of age on the pharmacokinetics of duloxetine in women

Skinner

Kuan

Skerjanec

et al. 2003

Brit J Clinical Pharma

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AimsThe effect of age on duloxetine pharmacokinetics was evaluated in healthy volunteers and in patients with urinary incontinence. MethodsTwenty-four healthy subjects (12 women 65-77 years, and 12 women 32-50 years) were given a single 40-mg oral dose of duloxetine in Study 1. Plasma concentrationtime data were analysed by noncompartmental pharmacokinetic methods. Sparse plasma samples were obtained from patients with urinary incontinence treated in two phase II studies: 70 women (24-77 years) who received duloxetine 20 mg day -1 , 30 mg day -1 , or 40 mg day -1 in Study 2A and 128 women (28-64 years) who received duloxetine 20 mg day -1 , 40 mg day -1 , or 80 mg day -1 in Study 2B. Based upon the combined data, a model was developed to characterize population pharmacokinetics of duloxetine using the nonlinear mixed-effects modelling prog ram (NONMEM). ResultsIn Study 1, the elderly ( ≥ 65 years) exhibited a statistically significant slower elimination rate constant l z compared with younger subjects {elderly-younger difference = -0.022 h -1 [95% confidence interval (CI) -0.036, -0.008]}. However, no statistically significant differences in either CL/F [elderly-younger difference = -17.4 l h -1 (95% CI -41.1, 6.23)] or V/F [elderly-younger difference = 115.9 l (95% CI -168.6, 400.4)] were observed. The population pharmacokinetic analysis of Studies 2A and 2B revealed that the CL/F of duloxetine decreased with increasing age. Despite statistical significance, the age effect only accounted for 3% of the interindividual variability in CL/F and unexplained sources of the variation in clearance were still substantial (> 50%). Adverse events were generally mild to moderate, and the incidence of adverse events was generally similar in elderly and non-elderly participants in these studies. ConclusionsWhereas the results suggest that age has an effect on duloxetine pharmacokinetics, primarily reflected as a slower l z in the elderly, the magnitude of mean changes in CL/F, or V/F was small relative to the large interindividual variation in pharmacokinetics. Elderly participants had a safety profile of duloxetine comparable to their younger counterparts. Specific dose recommendations for duloxetine in the elderly are not warranted. Effect of age on the pharmacokinetics of duloxetine in womenBr J Clin Pharmacol 57 :1 55

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Section: Studies 2a and 2bmentioning

confidence: 99%

Effect of age on the pharmacokinetics of duloxetine in women

Skinner

Kuan

Skerjanec

et al. 2003

Brit J Clinical Pharma

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“…Compared to the GC-MS method [19], the proposed method has higher extraction yields (>90% versus 75%) and better sensitivity (LOQ = 2 ng mL −1 versus 50 ng mL −1 ). When compared to the HPLC-FL method [18], the proposed method is certainly much more feasible, since it does not require any timeconsuming and expensive derivatisation step, and uses lower volumes of plasma (450 L instead of 1 mL), while reaching a better sensitivity level (LOQ = 2 ng mL −1 versus 5 ng mL −1 ). The HPLC-MS method briefly described by Lantz et al [12] has better sensitivity (0.5 ng mL −1 ), however it requires more expensive instrumentation.…”

Section: Resultsmentioning

confidence: 98%

“…The method is also selective: neither endogenous compounds nor any of the central nervous system drugs tested has produced any interference in the analysis of DLX in depressed patients' plasma. The use of SPE poses several advantages with respect to the liquid-liquid extraction procedures used by other authors [18,19]: in fact, the SPE procedure is faster and requires lower volumes of organic solvents. The proposed method is also advantageous for other reasons: it has high accuracy and a wide linearity range, which allows the determination of the analyte not only at therapeutic doses but also in overdose cases and when administered at sub-therapeutic doses (e.g., scarce patient compliance).…”

Section: Resultsmentioning

confidence: 99%

“…The first one [18] describes an HPLC method with fluorescence detection (HPLC-FL), after derivatisation with dansyl chloride, to determinate DLX and its main metabolite in plasma. The second one [19] describes a gas chromatographic method with mass spectrometric detection (GC-MS), which has been used for the toxicological analysis of DLX in post-mortem specimens.…”

Section: Introductionmentioning

confidence: 99%

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HPLC analysis of the novel antidepressant duloxetine in human plasma after an original solid-phase extraction procedure

Mercolini

Mandrioli

Cazzolla

et al. 2007

Journal of Chromatography B

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“…A GC-MS method was used for DLX analysis in post-mortem specimens after a liquid-liquid extraction procedure [12]. Other methods are based on HPLC, coupled to different detectors [9,[13][14][15][16]. In particular, one is based on HPLC with fluorescence detection after derivatisation with dansyl chloride, and analyses are carried out for DLX and its main metabolite in human plasma [13].…”

Section: Introductionmentioning

confidence: 99%