盐酸洛哌丁胺片吸光度法和曲线下面积法的建立与验证

H. Rivai, Renny Puspita, Sesry Misfadhila
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引用次数: 2

摘要

建立并验证了盐酸洛哌丁胺片的吸光度法和曲线下面积法。本研究以甲醇和盐酸0.1 N(9:1)为最佳溶剂,在波长259.00 nm处吸收最大。盐酸洛哌丁胺在200 ~ 600 ppm浓度范围内呈线性关系,吸光度法相关系数值为0.9998,曲线下面积分别为0.9865。结果表明,吸光度法和曲线下面积法测得的盐酸洛哌丁胺仿制片中盐酸洛哌丁胺的含量分别为105.71%和96.20%。吸光度法和曲线下面积法测定商标片中洛哌丁胺含量的结果分别为102.85%和98.57%。两种样品的含量均符合印尼药典V版90% -110%的要求。
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Development and Validation of Loperamide Hydrochloride Tablet Analysis Method with Absorbance and Area under Curve Methods Spectrophotometrically
Development and validation of loperamide hydrochloride tablet method of analysis with absorbance method and area under the curve method have been done. This study used methanol and hydrochloric acid 0.1 N (9: 1) as the best solvent with maximum absorption at wavelength 259.00 nm. Linearity of loperamide hydrochloride was obtained in the concentration range 200-600 ppm with correlation coefficient value with absorbance method and the areas under the curve method were 0.9998 and 0.9865, respectively. The results showed that the levels of loperamide hydrochloride in generic tablets obtained by absorbance method and the area under the curve method were 105.71% and 96.20%, respectively. The results of determination of loperamide levels in tablets of trademark obtained by absorbance method and the area under the curve method were 102.85% and 98.57%, respectively. The level of both samples met the requirements of Pharmacopoeia Indonesia edition V that is 90% -110%.
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