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

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

References

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