Advancement and Validation of Stability Representative RP-HPLC Assay Method of Desvenlafaxine In Pure And Pharmaceutical Dosage Form

[摘要] This paper portrays the advancement and approval of a solidness showing fluid chromatographic strategy for measure of desvenlafaxine in unadulterated and in plans utilizing X-Terra RP C18, 250x4.6 mm, 5 µm particle size column with detection at wavelength 226nm. In the present investigation the mobile phase comprising of sodium dihydrogen orthophosphate buffer (pH 4.0) and acetonitrile in the proportion of 60:40%/v with the Flow rate of 1.0ml/min and column temperature at surrounding temperature uncovered the better resolution and affectability for desvenlafaxine. The maintenance time of desvenlafaxine peak was about 3.632min independently. The created approach be accepted according to ICH regulations which incorporate framework appropriateness, particularity, linearity, exactness, accuracy, vigor, toughness, affectability, cutoff of detection and measurement contemplates and the outcomes were incorporated in this paper.

[学科分类] 药学

[关键词] Desvenlafaxine;stability indicating method;RP-HPLC;ICH regulations.