Development and Validation of HPLC Method for...

Development and Validation of HPLC Method for Venlafaxine HCL in Extended Release Tablet Formulation

Author Name : Mr. Ajinkya V. Gulhane, Ms. Pratiksha R. Meshram, Ms. Aachal S. Chimkar, Ms. Shubhada A. Ganvir, Ms. Shailaja W. Gawande, Dr. Anil P. Dewani, Dr. Anil V. Chandewar

ABSTRACT

A rapid and accurate high performance liquid chromatographic method has been developed for the Venlafaxine hydrochloride which was successfully applied for assay of extended-release tablet formulation. The elution was achieved by using a Kintex EVO C18 (250 cm x 4.6 mm, 5micron) maintained at temperature of 28˚C, in isocratic mode of analysis, column was equilibrated by mobile phase Methanol: Acetonitrile: Hexane sulphonic acid (0.1%) in ratio (35:35:30). The flow rate was set to 1.0mL/min and PDA detection done at wavelength of 225 nm. The retention time of Venlafaxine hydrochloride was found to be 2.90 min., respectively. The method was validated for system suitability, specificity, accuracy, liniearity, robustness. The system suitability, specificity results were found within acceptance criteria for developed method. The method was linear in the range of 40 % to 160 %, with correlation coefficient 0.9992. The percentage recovery for Venlafaxine hydrochloride was found to be 98% and 99.5%.

Keywords: HPLC, Venlafaxine hydrochloride, validation study.