ABSTRACT

This paper describes the reverse phase high performance liquid chromatographic method and it was validated as per ICH guidelines for the determination of impurity-F in Venlafaxine hydrochloride. Analysis was carried on shimadzu HPLC system with inertsil ODS-3V C18 column, (150mm x 4.6mm, 5?m) using filtered and degassed solutions containing a mixture of buffer and methanol (55:45) in isocratic mode as mobile phase with flow rate of 1.0ml/minute. The detection was carried out using UV detector set at 225nm. This method obeyed Beer’s law in the concentration range from 80% - 120% of venlafaxine hydrochloride. The validation was performed according to the ICH Guidelines Q2 (R1). The % RSD for system suitability was 0.23 & 0.64 for Venlafaxine hydrochloride and impurity-F respectively. Linearity was observed in the concentration range of 80%-120% were linear (R1=0.9999 & R2=0.9994). For precision the %RSD was 0.8 & 0.2 for Venlafaxine hydrochloride and impurity-F respectively. The percentage recovery was 100.76% from the capsule formulation. Signal to noise ratio for limit of detection and limit of quantification was found to be within 3-5 and less than 10 for Venlafaxine hydrochloride and impurity-F respectively. The percentage recover was good and the results obtained in this study demonstrate that the venlafaxine hydrochloride HPLC method described in the protocol is selective, linear, precise, rugged and robust for the determination of impurity in venlafaxine hydrochloride. Key words: Venlafaxine hydrochloride, impurity F, Reverse phase liquid chromatography, assay, validation, percentage recovery
Publication date: 01/10/2020

https://ijbpas.com/pdf/2020/October/MS_IJBPAS_2020_5218.pdf

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https://doi.org/10.31032/IJBPAS/2020/9.10.5218