Analytical Method Development and Validation of RP-HPLC Method for Estimation of Escitalopram in Bulk and Pharmaceutical dosage form
Keywords:
Escitalopram, RP-HPLC, Anti-depressant activity, Acetonitrile and Methanol, OPAAbstract
Objective: To develop and validate the RP-HPLC method for the estimation of an antidepressant drug Escitalopram
Methods: A Phenomenex C-18, 250 mm x 4.6 mm, 5 µm, and a mobile phase made of 0.05% OPA in water: methanol (40:60 v/v) were used for the chromatographic separation. The detection was performed at 238 nm using a 20 μl injection and a flow rate of 1 ml/min. According to ICH Q2 (R1) requirements, the method was validated using a variety of factors, including linearity, precision, accuracy, and robustness.
Results: The retention time was observed at 2.70 min. The method was found to be linear with a correlation coefficient (r²) of 0.9997.
Conclusion: This approach was proven to be quick, easy, cost-effective, and run time-efficient.The validated parameters manifest that the method is reliable, linear, accurate, and precise, as well as robust with minor variations in chromatographic parameters
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Bairagi SH, Ghosh RS. Development and evaluation of novel estimation techniques for in vitro dissolution study and validation protocol for escitalopram as antidepressant drug and their formulation. Int. J. Pharm. Pharm. Sci. 2020 Aug 1; 12:55-61.
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