Identification and Quantification of Venlafaxine Hydrochloride and Its Related Substance in API Using Reverse Phase - Liquid Chromatographic Method
Journal Title: Scholars Journal of Applied Medical Sciences - Year 2017, Vol 5, Issue 11
Abstract
Abstract: The present paper describes the reverse phase-high performance liquid chromatographic method and was validated as per ICH guidelines for the determination of related substances in venlafaxine hydrochloride. RP-Liquid chromatography technique was performed with pH 0.1% v/v TFA in water and 0.1% v/v TFA in acetonitrile as mobile phase at a flow rate of 1.0 mL/min on Waters 2489 UV 2695 pump, Waters 2998 PDA 2695 pump Software Empower 3, with photodiode array detector using symmetry C18, 250 x 4.6 mm, 5µm column with UV detection at 227 nm. % RSD for system suitability was 0.52 and 0.39 for venlafaxine hydrochloride and impurity- A respectively. The method is specific. Linearity were observed for venlafaxine hydrochloride and impurity- A, in the concentration range of 0.0006 and 0.006 were linear (R2 = 0.9999 and R2 = 0.9999). For precision, % RSD was 0.97 % and 1.39 for venlafaxine hydrochloride and impurity- A respectively. Accuracy is calculated as % recovery. % Recovery for accuracy levels at 50, 100 and 150 % L for venlafaxine hydrochloride and impurity- A were 101.67 ± 0.39, 105.56 ± 0.40, 102.49 ± 0.20 and 107.42 ± 0.44, 108.55 ± 0.20, 103.42± 0.18, respectively. . Signal to Noise ratio for Limit of detection and the limit of quantification were found to be in between 3-5 and > 10 for venlafaxine hydrochloride and impurity- A, respectively. The percent recovery was in good agreement; hence, the method is specific, simple, reproducible and accurate for the determination of venlafaxine hydrochloride. Keywords:Venlafaxine hydrochloride, estimation of related substances, liquid chromatography and percent recovery.
Authors and Affiliations
Yenisetty Ranganayakulu, TentuNageswara Rao
Keywords
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