Development and Validation of a Rapid and Sensitive Ultrahigh-Performance Liquid Chromatography with Diode Array Detection Method for Quantification of Sertraline in Pharmaceutical Formulations
Abstract
Objective: This study aimed to develop and validate a new, sensitive, fast, and simple ultrahighperformance liquid chromatography (UHPLC) method for the quantification of sertraline in pharmaceutical preparations and then apply it to commercial pharmaceutical preparations.
Methods: Ultrahigh-performance liquid chromatography with diode array detection was used in the study. In the method, methanol and deionized water containing 0.05% TFA (70:30, v/v) were used as the mobile phase, and the C18 column was used as the stationary phase. The flow rate was 1.0 mL/min, the injection volume was 20 μL, and the column temperature was 40°C. The detector was set at 254 nm.
Results: The retention time of sertraline was 2.1 minutes, and the analysis time of the method was 4 minutes. The equation of the calibration curve was determined as y=0.1096x − 0.0156 (R 0.9997). While the limit of detection and limit of quantitation values were 0.1 and 0.3 µg/mL, respectively, the method showed linearity between concentrations of 0.3 and 100 µg/mL. The analytical recovery of the method from the pharmaceutical preparation was within accepted limits (98%-102%). In addition, the relative error percentage and relative standard deviation values, which express the accuracy and precision parameters, respectively, were found to be less than 8%.
Conclusion: In the study, a UHPLC method with high sensitivity and a wide working range was developed for the quantification of sertraline in a short analysis time. As a result, the applicability of the developed method to pharmaceutical preparations has also been proven.
Ethical Statement
Ethical approval and informed consent are not required in our study as no research was conducted on human or animal specimens
Supporting Institution
The authors declare that this study received no financial support.
References
- 1. Núñez NA, Miola A, Frye MA. Examining age of onset phenotype in the spectrum of mood disorders. Int Clin Psychopharmacol. 2023;38(1):66-67. [CrossRef]
- 2. DeVane CL, Liston HL, Markowitz JS. Clinical pharmacokinetics of sertraline. Clin Pharmacokinet. 2002;41(15):1247-1266. [CrossRef]
- 3. Sanchez C, Reines EH, Montgomery SA. A comparative review of escitalopram, paroxetine, and sertraline: are they all alike? Int Clin Psychopharmacol. 2014;29(4):185-196. [CrossRef]
- 4. Bebawy LI, El-Kousy N, Suddik JK, Shokry M. Spectrophotometric determination of fluoxetine and sertraline using chloranil, 2, 3 dichloro-5, 6 dicyano benzoquinone and iodine. J Pharm Biomed Anal. 1999;21(1):133-142. [CrossRef]
- 5. Darwish IA. Development and validation of spectrophotometric methods for determination of fluoxetine, sertraline, and paroxetine in pharmaceutical dosage forms. J AOAC Int. 2005;88(1):38-45.
- 6. Erk N. Rapid and simple methods for quantitative analysis of some antidepressant in pharmaceutical formulations by using first derivative spectrophotometry and HPLC. Farmaco. 2003;58(12):1209- 1216. [CrossRef]
- 7. Singhvi I, Chaturvedi SC. Visible spectrophotometric and HPLC methods for the estimation of sertraline hydrochloride from tablet formulations. Indian J Pharm Sci. 2000;62(6):468-470.
- 8. Chaves AR, Moura BHF, Caris JA, Rabelo D, Queiroz MEC. The development of a new disposable pipette extraction phase based on polyaniline composites for the determination of levels of antidepressants in plasma samples. J Chromatogr A. 2015;1399:1-7. [CrossRef]
- 9. Adams AIH, Bergold AM. Doseamento do cloridrato de sertralina por cromatografia líquida de alta eficiência e volumetria em meio nãoaquoso. Rev Bras Cienc Farm J Pharm Sci. 2001;37(3):329-334.
- 10. Chen D, Jiang S, Chen Y, Hu Y. HPLC determination of sertraline in bulk drug, tablets and capsules using hydroxypropyl-β-cyclodextrin as mobile phase additive. J Pharm Biomed Anal. 2004;34(1):239-245.
- 11. Patil D, Raman B. Simultaneous estimation of sertraline & alprazolam in capsules by reverse phase liquid chromatography. Indian Drugs. 2001;38(12):638-641.
- 12. Chen X, Zheng S, Le J, et al. Ultrasound-assisted low-density solvent dispersive liquid–liquid microextraction for the simultaneous determination of 12 new antidepressants and 2 antipsychotics in whole blood by gas chromatography–mass spectrometry. J Pharm Biomed Anal. 2017;142:19-27. [CrossRef]
- 13. Truta L, Castro AL, Tarelho S, Costa P, Sales MGF, Teixeira HM. Antidepressants detection and quantification in whole blood samples by GC–MS/MS, for forensic purposes. J Pharm Biomed Anal. 2016;128:496-503. [CrossRef]
- 14. Sistik P, Turjap M, Iordache AM, Saldanha HMEB, Lemr K, Bednar P. Quantification of selected antidepressants and antipsychotics in clinical samples using chromatographic methods combined with mass spectrometry: a review (2006-2015). Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016;160(1):39-53. [CrossRef]
- 15. Feng Y, Zheng M, Zhang X, et al. Analysis of four antidepressants in plasma and urine by gas chromatography-mass spectrometry combined with sensitive and selective derivatization. J Chromatogr A. 2019;1600:33-40. [CrossRef]
- 16. Boumba VA, Rallis G, Petrikis P, Vougiouklakis T, Mavreas V. Determination of clozapine, and five antidepressants in human plasma, serum and whole blood by gas chromatography–mass spectrometry: A simple tool for clinical and postmortem toxicological analysis. J Chromatogr B Analyt Technol Biomed Life Sci. 2016;1038:43-48.
- 17. Papoutsis I, Khraiwesh A, Nikolaou P, Pistos C, Spiliopoulou C, Athanaselis S. A fully validated method for the simultaneous determination of 11 antidepressant drugs in whole blood by gas chromatography–mass spectrometry. J Pharm Biomed Anal. 2012;70:557-562. [CrossRef]
- 18. Sasajima Y, Lim LW, Takeuchi T, Suenami K, Sato K, Takekoshi Y. Simultaneous determination of antidepressants by non-aqueous capillary electrophoresis-time of flight mass spectrometry. J Chromatogr A. 2010;1217(48):7598-7604. [CrossRef]
- 19. Wu HF, Kailasa SK, Yan JY, Chin CC, Ku HY. Comparison of single-drop microextraction with microvolume pipette extraction directly coupled with capillary electrophoresis for extraction and separation of tricyclic antidepressant drugs. J Ind Eng Chem. 2014;20(4):2071- 2076. [CrossRef]
- 20. Himmelsbach M, Buchberger W, Klampfl CW. Determination of antidepressants in surface and waste water samples by capillary electrophoresis with electrospray ionization mass spectrometric detection after preconcentration using off-line solid-phase extraction. Electrophoresis. 2006;27(5-6):1220-1226.
- 21. MontenarhD, Wernet MP, Hopf M, Maurer HH, Schmidt PH, EwaldAH. Quantification of 33 antidepressants by LC-MS/MS - Comparative validation in whole blood, plasma, and serum. Anal Bioanal Chem. 2014;406(24):5939-5953. [CrossRef]
- 22. Zheng MM, Wang ST, Hu WK, Feng YQ. In-tube solid-phase microextraction based on hybrid silica monolith coupled to liquid chromatography–mass spectrometry for automated analysis often antidepressants in human urine and plasma. J Chromatogr A. 2010;1217(48):7493-7501. [CrossRef]
- 23. Zheng M, Zhang C, Wang L, et al. Determination of nine mental drugs in human plasma using solid-phase supported liquid-liquid extraction and HPLC-MS/MS. Microchem J. 2021;160:105647.
- 24. ICH Harmonised tripartite guideline validation of analytical procedures: text and methodology Q2(R1) Retrieved from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2014. Published online 2014. Accessed November 17, 2023. Available at: [CrossRef]
- 25. Önal A, Kepekçi SE, Çetin SM, Ertürk S. Spectrophotometric determination of certain antidepressants in pharmaceutical preparations. J AOAC Int. 2006;89(4):966-971. [CrossRef]
- 26. Adams AIH, Bergold AM. Assay of sertraline in tablets and drug substance by liquid chromatography. J Pharm Biomed Anal. 2001;26(3):505-508. [CrossRef]
Development and Validation of a Rapid and Sensitive Ultrahigh-Performance Liquid Chromatography with Diode Array Detection Method for Quantification of Sertraline in Pharmaceutical Formulations
Abstract
Objective: This study aimed to develop and validate a new, sensitive, fast, and simple ultrahighperformance liquid chromatography (UHPLC) method for the quantification of sertraline in pharmaceutical preparations and then apply it to commercial pharmaceutical preparations.
Methods: Ultrahigh-performance liquid chromatography with diode array detection was used in the study. In the method, methanol and deionized water containing 0.05% TFA (70:30, v/v) were used as the mobile phase, and the C18 column was used as the stationary phase. The flow rate was 1.0 mL/min, the injection volume was 20 μL, and the column temperature was 40°C. The detector was set at 254 nm.
Results: The retention time of sertraline was 2.1 minutes, and the analysis time of the method was 4 minutes. The equation of the calibration curve was determined as y=0.1096x − 0.0156 (R 0.9997). While the limit of detection and limit of quantitation values were 0.1 and 0.3 µg/mL, respectively, the method showed linearity between concentrations of 0.3 and 100 µg/mL. The analytical recovery of the method from the pharmaceutical preparation was within accepted limits (98%-102%). In addition, the relative error percentage and relative standard deviation values, which express the accuracy and precision parameters, respectively, were found to be less than 8%.
Conclusion: In the study, a UHPLC method with high sensitivity and a wide working range was developed for the quantification of sertraline in a short analysis time. As a result, the applicability
of the developed method to pharmaceutical preparations has also been proven.
Ethical Statement
Ethical approval and informed consent are not required in our study as no research was conducted on human or animal specimens.
Supporting Institution
The authors declare that this study received no financial support.
References
- 1. Núñez NA, Miola A, Frye MA. Examining age of onset phenotype in the spectrum of mood disorders. Int Clin Psychopharmacol. 2023;38(1):66-67. [CrossRef]
- 2. DeVane CL, Liston HL, Markowitz JS. Clinical pharmacokinetics of sertraline. Clin Pharmacokinet. 2002;41(15):1247-1266. [CrossRef]
- 3. Sanchez C, Reines EH, Montgomery SA. A comparative review of escitalopram, paroxetine, and sertraline: are they all alike? Int Clin Psychopharmacol. 2014;29(4):185-196. [CrossRef]
- 4. Bebawy LI, El-Kousy N, Suddik JK, Shokry M. Spectrophotometric determination of fluoxetine and sertraline using chloranil, 2, 3 dichloro-5, 6 dicyano benzoquinone and iodine. J Pharm Biomed Anal. 1999;21(1):133-142. [CrossRef]
- 5. Darwish IA. Development and validation of spectrophotometric methods for determination of fluoxetine, sertraline, and paroxetine in pharmaceutical dosage forms. J AOAC Int. 2005;88(1):38-45.
- 6. Erk N. Rapid and simple methods for quantitative analysis of some antidepressant in pharmaceutical formulations by using first derivative spectrophotometry and HPLC. Farmaco. 2003;58(12):1209- 1216. [CrossRef]
- 7. Singhvi I, Chaturvedi SC. Visible spectrophotometric and HPLC methods for the estimation of sertraline hydrochloride from tablet formulations. Indian J Pharm Sci. 2000;62(6):468-470.
- 8. Chaves AR, Moura BHF, Caris JA, Rabelo D, Queiroz MEC. The development of a new disposable pipette extraction phase based on polyaniline composites for the determination of levels of antidepressants in plasma samples. J Chromatogr A. 2015;1399:1-7. [CrossRef]
- 9. Adams AIH, Bergold AM. Doseamento do cloridrato de sertralina por cromatografia líquida de alta eficiência e volumetria em meio nãoaquoso. Rev Bras Cienc Farm J Pharm Sci. 2001;37(3):329-334.
- 10. Chen D, Jiang S, Chen Y, Hu Y. HPLC determination of sertraline in bulk drug, tablets and capsules using hydroxypropyl-β-cyclodextrin as mobile phase additive. J Pharm Biomed Anal. 2004;34(1):239-245.
- 11. Patil D, Raman B. Simultaneous estimation of sertraline & alprazolam in capsules by reverse phase liquid chromatography. Indian Drugs. 2001;38(12):638-641.
- 12. Chen X, Zheng S, Le J, et al. Ultrasound-assisted low-density solvent dispersive liquid–liquid microextraction for the simultaneous determination of 12 new antidepressants and 2 antipsychotics in whole blood by gas chromatography–mass spectrometry. J Pharm Biomed Anal. 2017;142:19-27. [CrossRef]
- 13. Truta L, Castro AL, Tarelho S, Costa P, Sales MGF, Teixeira HM. Antidepressants detection and quantification in whole blood samples by GC–MS/MS, for forensic purposes. J Pharm Biomed Anal. 2016;128:496-503. [CrossRef]
- 14. Sistik P, Turjap M, Iordache AM, Saldanha HMEB, Lemr K, Bednar P. Quantification of selected antidepressants and antipsychotics in clinical samples using chromatographic methods combined with mass spectrometry: a review (2006-2015). Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016;160(1):39-53. [CrossRef]
- 15. Feng Y, Zheng M, Zhang X, et al. Analysis of four antidepressants in plasma and urine by gas chromatography-mass spectrometry combined with sensitive and selective derivatization. J Chromatogr A. 2019;1600:33-40. [CrossRef]
- 16. Boumba VA, Rallis G, Petrikis P, Vougiouklakis T, Mavreas V. Determination of clozapine, and five antidepressants in human plasma, serum and whole blood by gas chromatography–mass spectrometry: A simple tool for clinical and postmortem toxicological analysis. J Chromatogr B Analyt Technol Biomed Life Sci. 2016;1038:43-48.
- 17. Papoutsis I, Khraiwesh A, Nikolaou P, Pistos C, Spiliopoulou C, Athanaselis S. A fully validated method for the simultaneous determination of 11 antidepressant drugs in whole blood by gas chromatography–mass spectrometry. J Pharm Biomed Anal. 2012;70:557-562. [CrossRef]
- 18. Sasajima Y, Lim LW, Takeuchi T, Suenami K, Sato K, Takekoshi Y. Simultaneous determination of antidepressants by non-aqueous capillary electrophoresis-time of flight mass spectrometry. J Chromatogr A. 2010;1217(48):7598-7604. [CrossRef]
- 19. Wu HF, Kailasa SK, Yan JY, Chin CC, Ku HY. Comparison of single-drop microextraction with microvolume pipette extraction directly coupled with capillary electrophoresis for extraction and separation of tricyclic antidepressant drugs. J Ind Eng Chem. 2014;20(4):2071- 2076. [CrossRef]
- 20. Himmelsbach M, Buchberger W, Klampfl CW. Determination of antidepressants in surface and waste water samples by capillary electrophoresis with electrospray ionization mass spectrometric detection after preconcentration using off-line solid-phase extraction. Electrophoresis. 2006;27(5-6):1220-1226.
- 21. MontenarhD, Wernet MP, Hopf M, Maurer HH, Schmidt PH, EwaldAH. Quantification of 33 antidepressants by LC-MS/MS - Comparative validation in whole blood, plasma, and serum. Anal Bioanal Chem. 2014;406(24):5939-5953. [CrossRef]
- 22. Zheng MM, Wang ST, Hu WK, Feng YQ. In-tube solid-phase microextraction based on hybrid silica monolith coupled to liquid chromatography–mass spectrometry for automated analysis often antidepressants in human urine and plasma. J Chromatogr A. 2010;1217(48):7493-7501. [CrossRef]
- 23. Zheng M, Zhang C, Wang L, et al. Determination of nine mental drugs in human plasma using solid-phase supported liquid-liquid extraction and HPLC-MS/MS. Microchem J. 2021;160:105647.
- 24. ICH Harmonised tripartite guideline validation of analytical procedures: text and methodology Q2(R1) Retrieved from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2014. Published online 2014. Accessed November 17, 2023. Available at: [CrossRef]
- 25. Önal A, Kepekçi SE, Çetin SM, Ertürk S. Spectrophotometric determination of certain antidepressants in pharmaceutical preparations. J AOAC Int. 2006;89(4):966-971. [CrossRef]
- 26. Adams AIH, Bergold AM. Assay of sertraline in tablets and drug substance by liquid chromatography. J Pharm Biomed Anal. 2001;26(3):505-508. [CrossRef]
Details
| Primary Language | English |
|---|---|
| Subjects | Pharmacology and Pharmaceutical Sciences (Other) |
| Journal Section | Research Articles |
| Authors | |
| Publication Date | January 17, 2024 |
| Submission Date | November 18, 2023 |
| Acceptance Date | December 11, 2023 |
| Published in Issue | Year 2024 Volume: 4 Issue: 1 |
Content of this journal is licensed under a Creative Commons Attribution NonCommercial 4.0 International License