Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence
A simple, rapid, and sensitive method of liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of vardenafil in rabbit plasma. A simple protein precipitation method with ice-cold acetonitrile was used for plasma extraction. The mass transi...
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my.um.eprints.284272022-08-09T07:26:43Z http://eprints.um.edu.my/28427/ Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence Gan, Kok Zheng Widodo, Riyanto Teguh Chik, Zamri Teh, Lay Kek Rofiee, Mohd Salleh Mohamad Yusof, Mohd Izwan QD Chemistry RS Pharmacy and materia medica A simple, rapid, and sensitive method of liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of vardenafil in rabbit plasma. A simple protein precipitation method with ice-cold acetonitrile was used for plasma extraction. The mass transitions m/z 489 -> 151 and m/z 390 -> 169 were used to measure vardenafil and tadalafil (internal standard), respectively, with a total assay run time of 6 min. The limit of detection was 0.2 ng/mL. The assay was reproducible with intra-assay and interassay precision ranging 1.17%-9.17% and 1.31%-5.86%, respectively. There was also good intra-assay and interassay accuracy between 89.3%-105.3% and 94%-102% of the expected value, respectively. The linearity range was 0.5-60 ng/mL in rabbit plasma (r(2) >= 0.99). The measured AUC from 0 to 24 h (AUG(0-24t)) for the test and reference formulations were 174.38 +/- 95.91 and 176.45 +/- 76.88, respectively. For the test, C-max and T(ma)x were 75.36 +/- 59.53 ng/mL and 1.42 +/- 0.19 h, whereas, for the reference, these were 58.22 +/- 36.11 ng/mL and 2.04 +/- 0.33 h, respectively. The test formulation achieved a slightly lower AUG, 24 , value (p > 0.05), higher C-max values (p > 0.05), faster T-max (p < 0.05), and almost equal bioavailability compared with the reference formulation. Hindawi Ltd 2021-03-26 Article PeerReviewed Gan, Kok Zheng and Widodo, Riyanto Teguh and Chik, Zamri and Teh, Lay Kek and Rofiee, Mohd Salleh and Mohamad Yusof, Mohd Izwan (2021) Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence. International Journal of Analytical Chemistry, 2021. ISSN 1687-8760, DOI https://doi.org/10.1155/2021/5590594 <https://doi.org/10.1155/2021/5590594>. 10.1155/2021/5590594 |
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QD Chemistry RS Pharmacy and materia medica Gan, Kok Zheng Widodo, Riyanto Teguh Chik, Zamri Teh, Lay Kek Rofiee, Mohd Salleh Mohamad Yusof, Mohd Izwan Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence |
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A simple, rapid, and sensitive method of liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of vardenafil in rabbit plasma. A simple protein precipitation method with ice-cold acetonitrile was used for plasma extraction. The mass transitions m/z 489 -> 151 and m/z 390 -> 169 were used to measure vardenafil and tadalafil (internal standard), respectively, with a total assay run time of 6 min. The limit of detection was 0.2 ng/mL. The assay was reproducible with intra-assay and interassay precision ranging 1.17%-9.17% and 1.31%-5.86%, respectively. There was also good intra-assay and interassay accuracy between 89.3%-105.3% and 94%-102% of the expected value, respectively. The linearity range was 0.5-60 ng/mL in rabbit plasma (r(2) >= 0.99). The measured AUC from 0 to 24 h (AUG(0-24t)) for the test and reference formulations were 174.38 +/- 95.91 and 176.45 +/- 76.88, respectively. For the test, C-max and T(ma)x were 75.36 +/- 59.53 ng/mL and 1.42 +/- 0.19 h, whereas, for the reference, these were 58.22 +/- 36.11 ng/mL and 2.04 +/- 0.33 h, respectively. The test formulation achieved a slightly lower AUG, 24 , value (p > 0.05), higher C-max values (p > 0.05), faster T-max (p < 0.05), and almost equal bioavailability compared with the reference formulation. |
format |
Article |
author |
Gan, Kok Zheng Widodo, Riyanto Teguh Chik, Zamri Teh, Lay Kek Rofiee, Mohd Salleh Mohamad Yusof, Mohd Izwan |
author_facet |
Gan, Kok Zheng Widodo, Riyanto Teguh Chik, Zamri Teh, Lay Kek Rofiee, Mohd Salleh Mohamad Yusof, Mohd Izwan |
author_sort |
Gan, Kok Zheng |
title |
Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence |
title_short |
Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence |
title_full |
Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence |
title_fullStr |
Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence |
title_full_unstemmed |
Liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence |
title_sort |
liquid chromatography-tandem mass spectrometry method for the determination of vardenafil and its application of bioequivalence |
publisher |
Hindawi Ltd |
publishDate |
2021 |
url |
http://eprints.um.edu.my/28427/ |
_version_ |
1740826013424680960 |
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13.2014675 |