Recent Study on Development and Validation of Loperamide Hydrochloride Tablet Analysis Method with Absorbance and Area under Curve Methods Spectrophotometrically

H. Rivai, Renny Puspita, Sesry Misfadhila
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Abstract

Development and validation of loperamide hydrochloride tablet method of analysis have been done by using the absorbance method and area under the curve method. This study used methanol and hydrochloric acid 0.1 N (9:1) as the best solvent with maximum absorption at wavelength 259.00 nm. The linearity of loperamide hydrochloride was obtained in the concentration range 200-600 ppm with a correlation coefficient value with the 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%. The analysis of loperamide hydrochloride in tablets by ultraviolet-visible spectrophotometry by absorbance method is valid while the area under the curve method is invalid for analysis of loperamide hydrochloride in tablets.
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盐酸洛哌丁胺片剂吸光度法和曲线下面积法分析方法的建立与验证
采用吸光度法和曲线下面积法建立了盐酸洛哌丁胺片的分析方法并进行了验证。本研究以0.1 N(9:1)的甲醇和盐酸为最佳溶剂,在波长259.00 nm处吸收最大。盐酸洛哌丁胺在200 ~ 600 ppm的浓度范围内线性良好,吸光度法的相关系数为0.9998,曲线下面积为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。紫外可见分光光度法测定片剂中盐酸洛哌丁胺含量有效,曲线下面积法测定片剂中盐酸洛哌丁胺含量无效。
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