Development and Validation of a Rapid and Sensitive Ultrahigh-Performance Liquid Chromatography with Diode Array Detection Method for Quantification of Sertraline in Pharmaceutical Formulations

Year 2024, Volume: 4 Issue: 1, 7 - 13, 17.01.2024

Mahmut Can Bebek Tuğrul Çağrı Akman

https://doi.org/10.5152/Pharmata.2024.23028

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.

Keywords

Pharmaceutical dosage forms, sertraline, UHPLC-DAD, validation

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.

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.

Keywords

Pharmaceutical dosage forms, sertraline, UHPLC-DAD, validation

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.

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