Validation of a solid-phase extraction high-performance liquid chromatographic assay for doxazosin

Jackman, Graham P.; Colagrande, F.; Louis, William J.

doi:10.1016/0378-4347(91)80129-z

Cited by 23 publications

(15 citation statements)

References 6 publications

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“…Although the method using special stationary phase, alumina-based column and glass-bead guard column with high-pH mobile phase was reported (Fouda et al, 1988), such columns may not be available in most laboratories and the mobile phase may deteriorate the columns and HPLC instrument. For separation of the doxazosin from plasma, the use of solid-phase extraction has also been reported (Jackman et al, 1991), but the method was too expensive and lengthy compared with the liquid-liquid extraction procedure (Cowlishaw and 730 P. Sripalakit et al ORIGINAL RESEARCH Sharman, 1985). The quantification limit of doxazosin was found to be higher than 1 ng/mL (Cowlishaw and Sharman, 1985;Jackman et al, 1991).…”

Section: Introductionmentioning

confidence: 98%

“…For separation of the doxazosin from plasma, the use of solid-phase extraction has also been reported (Jackman et al, 1991), but the method was too expensive and lengthy compared with the liquid-liquid extraction procedure (Cowlishaw and 730 P. Sripalakit et al ORIGINAL RESEARCH Sharman, 1985). The quantification limit of doxazosin was found to be higher than 1 ng/mL (Cowlishaw and Sharman, 1985;Jackman et al, 1991).…”

Section: Introductionmentioning

confidence: 98%

“…1) is an α 1 -adrenoreceptor antagonist used for the treatment of patients with symptomatic benign prostatic hyperplasia and hypertension (Fulton et al, 1995;Lepor et al, 1997;Chung et al, 1999). Several methods have been described for the determination of doxazosin in human plasma (Fouda et al, 1988;Cowlishaw and Sharman, 1985;Jackman et al, 1991). Owing to the quinazoline structure, most of published assays for doxazosin and its members, prazosin, terazosin alfuzosin and tamsulosin, have been based on a high-performance liquid chromatography (HPLC) system with fluorescence detector (Cowlishaw and Sharman, 1985;Guinebault et al, 1986;Fouda et al, 1988;Jackman et al, 1991;Sekhar et al, 1998;Cheah et al, 2000;Macek et al, 2004).…”

Section: Introductionmentioning

confidence: 99%

“…Several methods have been described for the determination of doxazosin in human plasma (Fouda et al, 1988;Cowlishaw and Sharman, 1985;Jackman et al, 1991). Owing to the quinazoline structure, most of published assays for doxazosin and its members, prazosin, terazosin alfuzosin and tamsulosin, have been based on a high-performance liquid chromatography (HPLC) system with fluorescence detector (Cowlishaw and Sharman, 1985;Guinebault et al, 1986;Fouda et al, 1988;Jackman et al, 1991;Sekhar et al, 1998;Cheah et al, 2000;Macek et al, 2004). Although the method using special stationary phase, alumina-based column and glass-bead guard column with high-pH mobile phase was reported (Fouda et al, 1988), such columns may not be available in most laboratories and the mobile phase may deteriorate the columns and HPLC instrument.…”

Section: Introductionmentioning

confidence: 99%

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Validation and pharmacokinetic application of a method for determination of doxazosin in human plasma by high-performance liquid chromatography

Sripalakit

Nermhom

Saraphanchotiwitthaya

2006

Biomed. Chromatogr.

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A simple high-performance liquid chromatographic method for the determination of doxazosin in human plasma was developed and validated. Prazosin was used as internal standard. After extraction twice with ethyl acetate, chromatographic separation of doxazosin in human plasma was carried out using a reversed-phase Apollo C18 column (250 x 4.6 mm, 5 microm) with mobile phase of methanol-acetonitrile-0.04 m disodium hydrogen orthophosphate (22:22:56, v/v/v) adjusted to pH 4.9 with 0.9 m phosphoric acid and quantified by fluorescence detection operated with an excitation wavelength of 246 nm and an emission wavelength of 389 nm. The lower limit of quantification (LLOQ) of this assay was 1 ng/mL using 500 microL human plasma. Linearity was established over the range 1-25 ng/mL (r2 > 0.9994). The intra- and inter-day accuracy ranged from 90.5 to 104.4% and the coefficient of variation were not more than 8.6% for both intra- and inter-day precision, over the range of the calibration curve. The absolute recoveries of doxazosin and prazosin from human plasma were more than 91%. Doxazosin demonstrated acceptable short-term, long-term and freeze-thaw stability in human plasma. The assay has been successfully applied to plasma sample ana-lysis for pharmacokinetic study.

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Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Validation and pharmacokinetic application of a method for determination of doxazosin in human plasma by high-performance liquid chromatography

Sripalakit

Nermhom

Saraphanchotiwitthaya

2006

Biomed. Chromatogr.

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“…It is structurally similar to prazosin (Figure 1). [4][5][6] and pharmaceutical formulations [7][8][9][10] .…”

Section: Introduction: Doxazosin Mesylate (4-amino-2-[4-mentioning

confidence: 99%

Untitled

2012

IJPSR

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A simple, economic, selective, precise, and accurate High Performance liquid Chromatographic method for the analysis of Doxazosin in bulk drug and pharmaceutical formulations was developed and validated in the present study. The mobile phase consists of a mixture of Methanol and Potassium Dihydrogen Orthophosphate in the proportion 60: 40. And adjust the pH to 5.0 ± 0.05 with sodium hydroxide solution. This was found to give a sharp peak of Doxazosin at a retention time of 4.484 min. HPLC analysis of Doxazosin was carried out at a wavelength of 251nm with a flow rate of 1.0mL/min. The linear regression analysis data for the calibration curve showed a good linear relationship with a regression coefficient of 0.999 in the concentration range of 50 ppm to 150 ppm. The linear regression equation was y =28.34x-16.91. The developed method was employed with a high degree of precision and accuracy for the analysis of Doxazosin. The developed method was validated for accuracy, precision, robustness, detection and quantification limits as per the ICH guidelines. The wide linearity range, accuracy, sensitivity, short retention time and composition of the mobile phase indicated that this method is better for the quantification of Doxazosin.

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High-performance liquid chromatographic determination of doxazosin in human plasma for bioequivalence study of controlled release doxazosin tablets

Kim

Lee

Kang

et al. 2006

Biomed. Chromatogr.

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A highly sensitive high-performance liquid chromatographic quantification method with fluorescence detection was developed and validated for the determination of doxazosin in human plasma. The developed method employed one-step extraction of doxazosin from plasma matrix with ethyl acetate using propranolol as an internal standard. Chromatographic separation was obtained within 8.0 min using a reverse-phase Capcell-Pak C(18) column (150 x 4.6 mm i.d., 5 microm) and the mobile phase consisted of methanol-water containing 10 mM perchloric acid and 1.8 mM sodium heptane sulfonic acid (50:50, v/v) and was set at a flow rate of 1.5 mL/min. The calibration curve constructed was linear in the range of 0.3-50.0 ng/mL. The proposed method achieved a lower limit of quantification of 0.3 ng/mL, better than the reported HPLC methods. Average recoveries of doxazosin and the internal standard from human plasma matrix were 87.0 and 85.9%, respectively. The present method was validated by evaluating the precision and accuracy for inter- and intraday variation in the concentration range 0.3-50 ng/mL. The precision values expressed as relative standard deviations in the inter- and intraday validation were 1.17-6.29 and 0.84-5.94%, respectively. This method was successfully applied to the bioequivalence study of two doxazosin controlled release tablets in healthy, male human subjects.

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Validation of a solid-phase extraction high-performance liquid chromatographic assay for doxazosin

Cited by 23 publications

References 6 publications

Validation and pharmacokinetic application of a method for determination of doxazosin in human plasma by high-performance liquid chromatography

Validation and pharmacokinetic application of a method for determination of doxazosin in human plasma by high-performance liquid chromatography

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High-performance liquid chromatographic determination of doxazosin in human plasma for bioequivalence study of controlled release doxazosin tablets

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