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Different stability-indicating chromatographic techniques for the determination of netobimin

机译:不同的指示稳定度的色谱技术测定奈考比敏

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Two simple, accurate, and sensitive methods were developed for the determination of netobimin in the presence of its degradation product. Method (A) was an HPLC method, performed on C18 column using acetonitrile/methanol/0. 01M potassium dihydrogen phosphate (56:14:30 by volume) as a mobile phase with a flow rate of 0.5mL/min. Detection was performed at 254nm. Method (B) was a TLC method, using silica gel 60 F254 plates; the optimized mobile phase was toluene/methanol/chloroform/ammonium hydroxide (5:4:6:0.1 by volume). The spots were scanned densitometrically at 346nm. Linearity ranges were 1-10g/mL for method (A) and 0.5-5g/band for method (B), and the mean percentage recoveries were 99.3±0.7 % and 99.7±0.7 % for methods (A) and (B), respectively. The proposed methods were found to be specific for netobimin in the presence of up to 90% of its degradation product. Statistical comparison between the results obtained by these methods and the manufacturer method was done, and no significance difference was obtained.
机译:开发了两种简单,准确和灵敏的方法测定存在降解产物的奈替比敏。方法(A)是HPLC方法,在C18柱上使用乙腈/甲醇/ 0进行。 01M磷酸二氢钾(体积比为56:14:30)作为流动相,流速为0.5mL / min。在254nm处进行检测。方法(B)是TLC法,使用硅胶60 F254板;优化的流动相为甲苯/甲醇/氯仿/氢氧化铵(体积比为5:4:6:0.1)。在346nm处光密度扫描斑点。方法(A)的线性范围为1-10g / mL,方法(B)的线性范围为0.5-5g /条带,方法(A)和(B)的平均回收率分别为99.3±0.7%和99.7±0.7%,分别。发现拟议的方法在高达90%的降解产物存在下对奈替比明具有特异性。通过这些方法获得的结果与制造商方法之间进行了统计比较,没有发现显着性差异。

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