Direct high-performance liquid chromatographic determination of the enantiomers of alfuzosin in plasma on a second-generation α1-acid glycoprotein chiral stationary phase

Rouchouse, A.; Manoha, Martine; Durand, Alain; Thénot, Jean Paul

doi:10.1016/s0021-9673(01)91608-5

Cited by 26 publications

(12 citation statements)

References 12 publications

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“…No interferences from endogenous plasma components or other sources were found and no "cross talk" effect was observed in plasma samples. The on-column loading of alfuzosin (125 pg) and solifenacin (300 pg) per injection volume was very less compared to all other reported procedures [16][17][18][19][20][21]. The validation data demonstrates good precision and accuracy of the method.…”

Section: Resultsmentioning

confidence: 82%

“…Few assays are reported in literature for the determination of alfuzosin in biological matrices. Rouchouse et al [16] have determined enantiomers of alfuzosin in human plasma on a second-generation alpha 1 -acid glycoprotein chiral stationary by high-performance liquid chromatography. The limit of quantification for each isomer was 1 ng/mL.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Highly sensitive and rapid LC–ESI-MS/MS method for the simultaneous quantification of uroselective α1-blocker, alfuzosin and an antimuscarinic agent, solifenacin in human plasma

Mistri

Jangid

Pudage

et al. 2008

Journal of Chromatography B

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Section: Resultsmentioning

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Highly sensitive and rapid LC–ESI-MS/MS method for the simultaneous quantification of uroselective α1-blocker, alfuzosin and an antimuscarinic agent, solifenacin in human plasma

Mistri

Jangid

Pudage

et al. 2008

Journal of Chromatography B

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“…A method for determining alfuzosin in human plasma was validated using an API 3000 LC/MSIMS system with detection in the range of 0.05 to 30.00 ng/mL and Aquacil C18 column (100 × 2.1 mm, 5 μ m) was attached for separation [34, 35]. The interface used with the API 3000 LC MS/MS was a TurbolonSpray.…”

Section: Methodsmentioning

confidence: 99%

In Vitro-In Vivo Correlation Evaluation of Generic Alfuzosin Modified Release Tablets

Sanki

Mandal

2012

ISRN Toxicology

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Alfuzosin, a selective alpha-1a antagonistis is the most recently approved AARAS, with limited cardiac toxicity and exclusively used for lower urinary tract syndromes (LUTS). In order to reduce pill burden and better patient compliance modified release (MR) formulations have been developed. Alfuzosin MR tablet was developed by the use of hot-melt granulation techniques using mono- and diglycerides as rate controlling membranes to minimize health care cost and uses of costly excipients. The other purpose of the study was to evaluate in vitro-in vivo performance of the scale up batch in healthy human subjects for commercialization. The blend uniformity (mean ± RSD%), assay, cumulative percent dissolution at 24 h, hardness, and friability of the biobatch were 100.2 ± 0.05%, 100.43 ± 0.023%, 93.98%, 4.5 kg, 5 min, and 0.08%, respectively. The in vivo pharmacokinetic parameters under fasting conditions between test and reference formulations (Uroxatral 10 mg extended release tablets) were comparable. The 90% CI, geometric mean ratio (%) and power of C max, AUCT, and AUCI of the fasting study for the test and reference formulation were 99.03% to 122.78%, 109%, 0.998; 92.94% to 116.71%, 104%, 1; 98.17% to 124.01%, 110% 1, respectively. The scale up biobatch showed negligible difference in in vitro properties with respect to the pilot batch. The formulation developed with these agents was safe to use as there were no serious adverse events developed during the conduction of the clinical trial on the healthy subjects. Furthermore, the developed formulation was bioequivalent with respect to rate and extends of absorption to the reference formulation.

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“…Several analytical methods that have been reported for determination of ALH in biological fluids and pharmaceutical formulation which includes Spectrophotometric and Colorimetric methods [3][4][5][6][7], voltammetry method [8], Direct high-performance liquid chromatographic method is also reported for the determination of enantiomers of ALH in plasma [9,10]. RP-HPLC method [11][12][13][14], Liquid chromatography-tandem mass spectrometry method [15], validated HPLC and HPTLC stability-indicating methods [16,17] RP-HPLC method for simultaneous estimation of Alfuzosin Hydrochloride and Dutasteride [18,19].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of New RP-HPLC Method for the Estimation of Alfuzosin Hydrochloride in Bulk and Tablet Dosage Form

Patil¹,

Devdhe²,

Kale³

et al. 2013

AJAC

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A reverse phase high performance liquid chromatographic method (HPLC) has been developed for the estimation of Alfuzosin hydrochloride (ALH) in the pharmaceutical formulation using RP-C18 column. The mobile phase (Tetrahydrofuran, Acetonitrile and buffer (pH 3.50) was pumped at a flow rate of 1.5 ml/min in the ratio of 1:20:80 and the eluents were monitored at 254.0 nm. Linearity was obtained in the concentration range of 80 -120 µg/mL for ALH. The method was statistically validated and RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determination of Alfuzosin hydrochloride in bulk drugs and in pharmaceutical dosage form.

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Direct high-performance liquid chromatographic determination of the enantiomers of alfuzosin in plasma on a second-generation α1-acid glycoprotein chiral stationary phase

Cited by 26 publications

References 12 publications

Highly sensitive and rapid LC–ESI-MS/MS method for the simultaneous quantification of uroselective α1-blocker, alfuzosin and an antimuscarinic agent, solifenacin in human plasma

Highly sensitive and rapid LC–ESI-MS/MS method for the simultaneous quantification of uroselective α1-blocker, alfuzosin and an antimuscarinic agent, solifenacin in human plasma

In Vitro-In Vivo Correlation Evaluation of Generic Alfuzosin Modified Release Tablets

Development and Validation of New RP-HPLC Method for the Estimation of Alfuzosin Hydrochloride in Bulk and Tablet Dosage Form

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