Rapid, Sensitive, New and Simple UPLC-MS/MS Validated Method with Charged Surface Hybrid Column for Determination of Anti depression Drug Sertraline in Human Plasma and its Application to Bioequivalence Study | ||
| Bulletin of Pharmaceutical Sciences Assiut University | ||
| Articles in Press, Accepted Manuscript, Available Online from 27 August 2025 | ||
| Document Type: Original Article | ||
| DOI: 10.21608/bfsa.2025.401373.2627 | ||
| Authors | ||
| Yasser Abd El Fattah Elshayep* 1; waheed Mohamed Salem2; Abdelhameed Abdo Ismail3; Fathy Ibrahim Abd allah4 | ||
| 1Department of chemistry, Faculty of Science ,Menoufia university,ICBR | ||
| 2Faculty of Applied Health Science Technology, Menoufia University, Shebin Elkom, Egypt | ||
| 3Faculty of Science, Menoufia University, Shebin Elkom, Egypt | ||
| 4Faculty of Pharmacy, Department of Pharmaceutics and Industrial Pharmacy, Al- Azhar University, Cairo, Egypt | ||
| Abstract | ||
| Background: A rapid, simple, sensitive, reproducible, and RP-UPLC-MS/MS method was established and bioanalytically validated for determining Anti depression drug sertraline in human plasma. Methods: Sertraline was extracted from human plasma by protein precipitation technique using cooled acetonitrile. Sertraline was separated on a C18-column of Acquity UPLC CSH adjusted at 30oC and mass analyzed in a positive electrospray ionization mode. A simple mobile phase of formic acid (0.1%) and acetonitrile in a 50:50 (v/v) ratio was utilized at a flow rate of 300 L/min. the analysis of sertraline was carried out within 2 min over a range 0.5-50.0 ng/mL (r2=0.997). Results: Accuracy ranged from 95.0 to 104.0%, whereas inter- and intra-precision was not more than 15%. The results confirmed the sertraline stability under various conditions during analysis . Conclusion: The developed and bioanalytically validated method was effectively applied to a bioequivalence study of sertraline tablet (100 mg) in healthy Egyptian volunteers (n=31). | ||
| Keywords | ||
| Sertraline; anti-depressants; LC MS/MS; Human plasma; Bioanalytical | ||
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