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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| Format: | Article |
| Language: | English |
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Wiley
2021-01-01
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| Series: | International Journal of Analytical Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2021/5590594 |
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| author | Kok Zheng Gan Riyanto Teguh Widodo Zamri Chik Lay Kek Teh Mohd Salleh Rofiee Mohd Izwan Mohamad Yusof |
| author_facet | Kok Zheng Gan Riyanto Teguh Widodo Zamri Chik Lay Kek Teh Mohd Salleh Rofiee Mohd Izwan Mohamad Yusof |
| author_sort | Kok Zheng Gan |
| collection | DOAJ |
| description | 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 (r2 ≥ 0.99). The measured AUC from 0 to 24 h AUC0−24t for the test and reference formulations were 174.38 ± 95.91 and 176.45 ± 76.88, respectively. For the test, Cmax and Tmax 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 AUC0−24t value (p > 0.05), higher Cmax values (p > 0.05), faster Tmax (p < 0.05), and almost equal bioavailability compared with the reference formulation. |
| format | Article |
| id | doaj-art-2036465826bc4f4b986365d1ca09c470 |
| institution | Kabale University |
| issn | 1687-8760 1687-8779 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Analytical Chemistry |
| spelling | doaj-art-2036465826bc4f4b986365d1ca09c4702025-02-03T06:43:25ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792021-01-01202110.1155/2021/55905945590594Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Vardenafil and Its Application of BioequivalenceKok Zheng Gan0Riyanto Teguh Widodo1Zamri Chik2Lay Kek Teh3Mohd Salleh Rofiee4Mohd Izwan Mohamad Yusof5Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, MalaysiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, MalaysiaUniversity of Malaya Bioequivalence Testing Centre (UBAT), Department of Pharmacology, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, MalaysiaIntegrative Pharmacogenomics Institute (iPROMISE), Universiti Teknologi MARA, Bandar Puncak Alam 42300, Shah Alam, Selangor, MalaysiaIntegrative Pharmacogenomics Institute (iPROMISE), Universiti Teknologi MARA, Bandar Puncak Alam 42300, Shah Alam, Selangor, MalaysiaIntegrative Pharmacogenomics Institute (iPROMISE), Universiti Teknologi MARA, Bandar Puncak Alam 42300, Shah Alam, Selangor, MalaysiaA 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 (r2 ≥ 0.99). The measured AUC from 0 to 24 h AUC0−24t for the test and reference formulations were 174.38 ± 95.91 and 176.45 ± 76.88, respectively. For the test, Cmax and Tmax 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 AUC0−24t value (p > 0.05), higher Cmax values (p > 0.05), faster Tmax (p < 0.05), and almost equal bioavailability compared with the reference formulation.http://dx.doi.org/10.1155/2021/5590594 |
| spellingShingle | Kok Zheng Gan Riyanto Teguh Widodo Zamri Chik Lay Kek Teh Mohd Salleh Rofiee Mohd Izwan Mohamad Yusof Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Vardenafil and Its Application of Bioequivalence International Journal of Analytical Chemistry |
| title | 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_short | 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 |
| url | http://dx.doi.org/10.1155/2021/5590594 |
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