High-performance liquid chromatographic determination of finasteride in human plasma using direct injection with column switching

Takano, Terukazu; Hata, Shunsuke

doi:10.1016/0378-4347(95)00399-1

Cited by 34 publications

(21 citation statements)

References 7 publications

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“…These methods include high-performance liquid chromatography (HPLC) [11][12][13][14], polarography [15], liquid chromatography-tandem mass spectrometry [16][17][18] and an isotop dilution mass-spectrometric method [19]. Macek has reviewed about these published papers [20].…”

Section: Finasteridementioning

confidence: 99%

A rapid, simple, specific liquid chromatographic–electrospray mass spectrometry method for the determination of finasteride in human plasma and its application to pharmacokinetic study

Guo

Huang

Wong

et al. 2007

Journal of Pharmaceutical and Biomedical Analysis

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Section: Finasteridementioning

confidence: 99%

A rapid, simple, specific liquid chromatographic–electrospray mass spectrometry method for the determination of finasteride in human plasma and its application to pharmacokinetic study

Guo

Huang

Wong

et al. 2007

Journal of Pharmaceutical and Biomedical Analysis

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“…The quantitation of FIN in biological samples has been performed with several methods including high performance liquid chromatography (HPLC) [6][7][8], isotopedilution mass spectrometry [9], polarography [10], spectrophotometer [11], and high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS) [12][13][14][15][16][17][18][19]. Although HPLC is a well-established technique, it suffers from poor sensitivity and specificity.…”

Section: Introductionmentioning

confidence: 99%

A Stability Indicating UPLC Method for Finasteride and Its Related Impurities

Reddy¹,

Reddy²,

Veera³

et al. 2012

AJAC

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The objective of the present research work is to develop a gradient, reversed-phase liquid chromatographic (RP-UPLC) method for the determination of Finasteride in pharmaceutical bulk drugs for assay and its related impurities. The chromatographic separation was achieved on a Waters ACQUITY TM UPLC BEH Phenyl Column (150 mm × 2.1 mm, 1.7 µm), The gradient LC method employs solutions A and B as mobile phase. The solution A Contains 2.5 mM ortho phosphoric acid (Buffer) and solution B contains a mixture of acetonitrile and water in the ratio of (90:10 v/v). The flow rate was 0.22 ml/min and the detection wavelength was 210 nm. In the developed UPLC method, the resolution between Finasteride and its potential impurities, namely Imp-1, Imp-2, Imp-3 and Imp-4 was found to be greater than 2.0. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur in alkaline medium and oxidative stress conditions. Degradation product formed during oxidative hydrolysis was found to be Imp-1. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5%. The developed RP-UPLC method was validated with respect to linearity, accuracy, precision and robustness. The limit of quantification of Imp-1, Imp-2, Imp-3 and Imp-4 were 0.06, 0.06, 0.05 and 0.036% (of analyte concentration, i.e. 0.5 mg/ml) with 1 µl injection volume. The developed method was found to be linear in the range of 2.5 -15 µg/mL with correlation coefficient of 0.999 for assay procedures and found to be linear in the range of 0.05 -3 µg/mL with correlation coefficient of 0.999 for related impurities.

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“…The quantitation of finasteride in biological samples has been performed with several methods including high-performance liquid chromatography (HPLC) [6][7][8], isotope-dilution mass spectrometry [9], polarography [10], spectrophotometry [11], and highperformance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) [12][13][14][15][16][17][18]. Although HPLC is a well-established technique, it suffers from poor sensitivity and specificity.…”

Section: Introductionmentioning

confidence: 99%

“…Although HPLC is a well-established technique, it suffers from poor sensitivity and specificity. Previous methods have involved multistep sample preparations such as solid-phase extraction [8,18] and run times up to 38 min [6]. The addition of tandem MS/MS significantly enhances the sensitivity and specificity [13], but the chromatographic run times are still too long for high-throughput analyses [12,[14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Rapid determination of finasteride in human plasma by UPLC–MS/MS and its application to clinical pharmacokinetic study

Phapale¹,

Lee²,

Lim³

et al. 2010

Journal of Chromatography B

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High-performance liquid chromatographic determination of finasteride in human plasma using direct injection with column switching

Cited by 34 publications

References 7 publications

A rapid, simple, specific liquid chromatographic–electrospray mass spectrometry method for the determination of finasteride in human plasma and its application to pharmacokinetic study

A rapid, simple, specific liquid chromatographic–electrospray mass spectrometry method for the determination of finasteride in human plasma and its application to pharmacokinetic study

A Stability Indicating UPLC Method for Finasteride and Its Related Impurities

Rapid determination of finasteride in human plasma by UPLC–MS/MS and its application to clinical pharmacokinetic study

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