Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-LC, SHORT RUNTIME METHOD FOR THE ESTIMATION OF ESCITALOPRAM IN ESCITALOPRAM DOSAGE FORM

Bhupendrasinh K. Vaghela*, Surendra Singh Rao

Abstract

Introduction and Aim: A novel stability indicating short runtime (3.5 minutes) method was developed for quantitative determination of escitalopram in pharmaceutical dosage form. This method can able separate all six known impurities from escitalopram main peak. There is no reported method for the determination of Escitalopram by Ultra performance liquid chromatography in pharmaceutical dosage forms. This method is a relatively new technique giving new possibilities in liquid chromatography, especially concerning decrease of time and solvent consumption. Hence the author has made an attempt to develop a simple, sensitive and precise method for the determination of Escitalopram in Escitalopram oxalate tablet in pharmaceutical formulations by reducing the retention time of the drug. Method: The method was developed by using Waters BEH C8 (100mm x 2.1mm) 1.7μm column with mobile phase containing a potassium dihydrogen phosphate, Acetonitrile and methanol. The flow rate was 0.4 mL/min with column temperature of 25�C and detection wavelength at 239nm Results: In the precision study the % RSD for the result of escitalopram was below 1.5%.The method was linear with concentration rage of 6 μg/mL to 18 μg/mL with the correlation coefficient greater than 0.999 and % bias at 100% level are within + 2%. The percentage recoveries were calculated observed from 98.6% to 100.5%. Conclusion: The developed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision, ruggedness and robustness.

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