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Scholars Academic Journal of Pharmacy | Volume-7 | Issue-03
Development and Validation of Dimenhydrinate Analysis Method in Tablet with Absorbance Method and Method of Area under Curve with Ultraviolet Spectrophotometry
Harrizul Rivai, Nindry Selma Nofera, Zikra Azizah
Published: March 30, 2018 | 134 135
DOI: 10.21276/sajp.2018.7.3.8
Pages: 155-163
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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