| Autor: |
Hasnain, M. Saquib, Rao, Shireen, Singh, Manoj Kr., Vig, Nitin, Singh, Manish Kr., Budakoti, Subodh Kr., Ansari, Abdulla |
| Předmět: |
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| Zdroj: |
Journal of Pharmacy & Bioallied Sciences; Jan-Mar2013, Vol. 5 Issue 1, p74-79, 6p, 3 Charts, 6 Graphs |
| Abstrakt: |
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/x2) 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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