Abstract
A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of venlafaxine hydrochloride in tablet dosage forms. A Phenomenex Gemini C-18, 5 μm column having 250 × 4.6 mm i.d. in isocratic mode, with mobile phase containing methanol: 0.05 M potassium dihydrogen orthophosphate (70:30, v/v; pH 6.2) was used. The flow rate was 1.0 ml/min and effluents were monitored at 226 nm. Carbamazepine was used as an internal standard. The retention time of venlafaxine hydrochloride and carbamazepine were 3.7 min and 5.3 min, respectively. The method was validated for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, robustness and solution stability. Limit of detection and limit of quantification for estimation of venlafaxine hydrochloride were found to be 100 ng/ml and 300 ng/ml, respectively. Recoveries of venlafaxine hydrochloride in tablet formulations were found to be in the range of 99.02-101.68%. Proposed method was successfully applied for the quantitative determination of venlafaxine hydrochloride in tablet dosage forms.
Highlights
Human Buccal Epithelium-Permeability of Water, Mannitol, Testosterone and B-Adrenoceptor Anta-gonists
The results showed that for the solutions, retention time and peak area of venlafaxine hydrochloride and internal standard remained almost unchanged and no significant degradation was observed within the indicated period
Repeatability studies were carried out by estimating response of 3 different concentrations of venlafaxine hydrochloride (0.5, 2, 7 μg/ml) for three replicate determinations and results are reported in terms of relative standard deviation (RSD, Table 2)
Summary
Indexed in Ind MED, EMBASE/Excerpta Medica, International Pharmaceutical Abstracts, Chemical Abstracts. A stock solution of carbamazepine was prepared by accurately weighing 25 mg of the drug, transferring to 25 ml volumetric ßask, dissolving in 5 ml of methanol and diluting it upto mark with methanol Appropriate aliquot of this solution was further diluted with 10 ml of methanol to obtain Þnal standard solution of. Appropriate aliquots of standard venlafaxine hydrochloride stock solution (0.5 μg/ml) were taken in different 10 ml volumetric ßasks, followed by addition of 1 ml of standard carbamazepine standard solution (100 μg/ml) and resultant solutions were diluted up to the mark with mobile phase to obtain final concentration of 0.3, 1, 3, 5, 7, and. 9 μg/ml of venlafaxine hydrochloride and 10 μg/ml of carbamazepine, respectively These solutions were injected into chromatographic system and chromatograms were developed and peak area ratio was determined for each concentration of drug solution. The retention time of venlafaxine hydrochloride was found to be TABLE 2: SUMMARY OF VALIDATION PARAMETERS
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