Development and Validation of Dimenhydrinate Analysis Method in Tablet with Absorbance Method and Method of Area under Curve with Ultraviolet Spectrophotometry
Journal Title: Scholars Academic Journal of Pharmacy - Year 2018, Vol 7, Issue 3
Abstract
Abstract: Methods of ultraviolet spectrophotometry have been developed and validated for the analysis of dimenhydrinate in tablets with absorbance methods and methods of areas under the curve. This method uses 0.1 M HCl as a solvent and wavelength of 276.20 nm. The area under the curve is measured at a wavelength of 245.60-304.60 nm. The calibration curve was obtained in the concentration range of 10-30 μg / mL. Method of absorbance shows linear regression equation y = 0,105 + 0,019x and value r = 0.99983; wide-area-under-curve method shows linear regression equation y = 2.248 + 0.472x and r = 0.9985. Dimenhydrinate content in trademark tablets with absorbance method was 105.09% and with the method of area under the curve was 104.56%. Dimenhydrinate content in generic tablet with absorbance method is 93.86% and with method of area under the curve is 94.34%. Dimenhydrinate levels in both samples were eligible according to Pharmacopoeia edition V of 90-110%. The recovery and the relative standard deviation (RSD) obtained from both samples by absorbance method and the area-under-curve method met the requirements of the validation parameters, i.e. 80-120% and 0-2%, respectively. Statistical analysis showed that there was no significant difference between the two methods.
Authors and Affiliations
Harrizul Rivai, Nindry Selma Nofera, Zikra Azizah
Keywords
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