Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard
Purpose: For the determination of desloratadine (DES) and 3-OH desloratadine (3-OHD) in human plasma using deutrated desloratadine (DESD5) as internal standard (IS), a novel stability indicating liquid chromatography-tandem mass spectrometric method was developed and validated to support the clinica...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2013-01-01
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| Series: | Journal of Pharmacy and Bioallied Sciences |
| Subjects: | |
| Online Access: | http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2013;volume=5;issue=1;spage=74;epage=79;aulast=Hasnain |
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| author | M Saquib Hasnain Shireen Rao Manoj Kr. Singh Nitin Vig Manish Kr. Singh Subodh Kr. Budakoti Abdulla Ansari |
| author_facet | M Saquib Hasnain Shireen Rao Manoj Kr. Singh Nitin Vig Manish Kr. Singh Subodh Kr. Budakoti Abdulla Ansari |
| author_sort | M Saquib Hasnain |
| collection | DOAJ |
| description | Purpose: For the determination of desloratadine (DES) and 3-OH desloratadine (3-OHD) in human plasma using deutrated desloratadine (DESD5) as internal standard (IS), a novel stability indicating liquid chromatography-tandem mass spectrometric method was developed and validated to support the clinical advancement. Materials and Methods: The solid-phase extraction method used for sample preparation and calibration range was 100-11,000 pg/ml, for which a quadratic regression (1/x 2 ) was best fitted. The blank plasma was screened and observed free from any endogenous interference. Results: The accuracy (% nominal) at low limit of quantification LLOQ level for DES and 3-OHD was 100.4% and 99.9% whereas precision (%CV) was 4.6 and 5.1%. They (DES and 3-OHD) were stable in human plasma after five freeze-thaw cycles, at room temperature for 23.8 hour, bench top stability for 6.4 hour. Conclusion: This method fulfills all the regulatory requirements for selectivity, sensitivity, precision, accuracy, stability, goodness of fit, and ruggedness of the method for the determination of DES and 3-OHD in human plasma. |
| first_indexed | 2024-04-13T19:54:45Z |
| format | Article |
| id | doaj.art-8fdf6254ff0d40eb85cd6cb8f72de0b0 |
| institution | Directory Open Access Journal |
| issn | 0975-7406 0976-4879 |
| language | English |
| last_indexed | 2024-04-13T19:54:45Z |
| publishDate | 2013-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Pharmacy and Bioallied Sciences |
| spelling | doaj.art-8fdf6254ff0d40eb85cd6cb8f72de0b02022-12-22T02:32:23ZengWolters Kluwer Medknow PublicationsJournal of Pharmacy and Bioallied Sciences0975-74060976-48792013-01-0151747910.4103/0975-7406.106571Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standardM Saquib HasnainShireen RaoManoj Kr. SinghNitin VigManish Kr. SinghSubodh Kr. BudakotiAbdulla AnsariPurpose: For the determination of desloratadine (DES) and 3-OH desloratadine (3-OHD) in human plasma using deutrated desloratadine (DESD5) as internal standard (IS), a novel stability indicating liquid chromatography-tandem mass spectrometric method was developed and validated to support the clinical advancement. Materials and Methods: The solid-phase extraction method used for sample preparation and calibration range was 100-11,000 pg/ml, for which a quadratic regression (1/x 2 ) was best fitted. The blank plasma was screened and observed free from any endogenous interference. Results: The accuracy (% nominal) at low limit of quantification LLOQ level for DES and 3-OHD was 100.4% and 99.9% whereas precision (%CV) was 4.6 and 5.1%. They (DES and 3-OHD) were stable in human plasma after five freeze-thaw cycles, at room temperature for 23.8 hour, bench top stability for 6.4 hour. Conclusion: This method fulfills all the regulatory requirements for selectivity, sensitivity, precision, accuracy, stability, goodness of fit, and ruggedness of the method for the determination of DES and 3-OHD in human plasma.http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2013;volume=5;issue=1;spage=74;epage=79;aulast=HasnainDesloratadinemethod validation3-OH desloratadine |
| spellingShingle | M Saquib Hasnain Shireen Rao Manoj Kr. Singh Nitin Vig Manish Kr. Singh Subodh Kr. Budakoti Abdulla Ansari Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard Journal of Pharmacy and Bioallied Sciences Desloratadine method validation 3-OH desloratadine |
| title | Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard |
| title_full | Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard |
| title_fullStr | Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard |
| title_full_unstemmed | Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard |
| title_short | Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard |
| title_sort | development and validation of an improved lc ms ms method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard |
| topic | Desloratadine method validation 3-OH desloratadine |
| url | http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2013;volume=5;issue=1;spage=74;epage=79;aulast=Hasnain |
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