非洛地平原料药和制剂中hplc和RP-HPTLC方法的建立与验证

Jain Ps, Ansari Na, Surana Sj
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引用次数: 2

摘要

本研究的目的是建立高效薄层色谱-HPTLC (NP)和反相高效薄层色谱- RP-HPTLC (RP)分析原料药非洛地平的方法。分别以甲苯:甲醇(8:2 v/v)和乙腈:水:冰醋酸(8:2:1 v/v/v)为流动相,在250 μm层的硅胶60 F254和硅胶60 RP-18 TLC F254S预涂铝板上进行色谱分离。在237 nm处进行密度扫描。非洛地平在NP和RP的Rf值分别为0.40和0.53,方法的可靠性评估的线性评价被发现300 - 1800和500 - 3000 ng /乐队的r2 = 0.998相关系数随着方法的准确性的%恢复被发现从100和99 - 98 - 101±1.04%±0.47%,检测和量化的极限是11.51,34.90和29.90,90.61,分别。该方法可用于非洛地平原料药和制剂的常规分析。
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HPTLC and RP-HPTLC Method Development and Validation for the Estimation of Felodipine in Bulk and Pharmaceutical Formulation
The aim of this work is to establish developed and validated method for the pharmaceutical analysis of Felodipine in bulk and pharmaceutical formulation by High Performance Thin Layer Chromatography HPTLC (NP) and Reverse Phase-High Performance Thin Layer Chromatography RP-HPTLC (RP). Chromatographic separation was performed on Pre-coated aluminum plates with 250 μm layer of Silica gel 60 F254 and Silica gel 60 RP-18 TLC F254S using Toluene: Methanol (8:2 v/v) and acetonitrile: water: glacial acetic acid (8:2:1 v/v/v) as a mobile phase, respectively. Scanning was carried out densitometrically at 237 nm. The Rf value of Felodipine in NP and RP were 0.40 and 0.53 and the reliability of the method was assessed by the evaluation of linearity which was found to be 300-1800 and 500-3000 ng/band with the r2 =0.998 correlation coefficient along with the accuracy of the method in terms of % recovery was found to be from 98-101 ± 1.04 % and 99-100 ± 0.47 % and the limit of detection and quantification were 11.51, 34.90 and 29.90, 90.61, respectively. The method can be used for routine analysis of Felodipine in bulk and pharmaceutical formulation.
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