同时测定盐酸苯尼地平和替米沙坦含量的薄层色谱法的建立和稳定性验证

IF 1.3 Q4 CHEMISTRY, ANALYTICAL
Laxmibharti B. P. Mandal, Ketan Shah
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引用次数: 0

摘要

摘要建立了一种稳定性指示的高效薄层色谱(HPTLC)方法,用于同时测定盐酸苯尼地平(BEN)和替米沙坦(TEL)复方剂型的含量。它涉及使用预涂有硅胶60f254的HPTLC板和由甲醇:乙腈(1:9 v/v)组成的流动相。两种药物的测定均在237 nm下进行。药物经过酸碱水解、光解、热降解和氧化降解。BEN的线性关系为200 ~ 1000 ng/波段(r2 = 0.9917), TEL的线性关系为2000 ~ 10000 ng/波段(r2 = 0.9979)。BEN的检出限和定量限分别为3.28和9.94 ng/点,TEL的检出限和定量限分别为158.79和481.17 ng/点,精密度研究的相对标准偏差小于2%。确定了系统的各种适宜性参数。BEN和TEL的R f值分别为0.890±0.0105和0.173±0.0151。BEN和TEL的峰值分辨率分别为4.48,容量因子分别为0.21和0.74。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and validation of stability indicating thin‐layer chromatography method for simultaneous estimation of Benidipine hydrochloride and Telmisartan
Abstract For the simultaneous estimation of Benidipine hydrochloride (BEN) and Telmisartan (TEL) in combined pharmaceutical dosage form, a stability‐indicating high‐performance thin‐layer chromatography (HPTLC) method has been developed and validated. It involves the use of HPTLC plates pre‐coated with silica gel 60F 254 and a mobile phase comprising of Methanol: Acetonitrile (1:9 v/v). The measurements of both drugs were performed at 237 nm. The drugs were subjected to acid‐alkali hydrolysis, photolytic, thermal, and oxidation degradation. The linearity of BEN was found to be between 200–1000 ng/band (R 2 = 0.9917), while for TEL, linearity was found to be between 2000 and 10000 ng/band (R 2 = 0.9979). The limit of detection and limit of quantitation were found to be 3.28 and 9.94 ng/spot for BEN and 158.79 and 481.17 ng/spot for TEL. The % relative standard deviation of the precision study was determined to be less than 2%. Various system suitability parameters were determined. The R f values of BEN and TEL were found to be 0.890 ± 0.0105 and 0.173 ± 0.0151, respectively. The resolution between BEN and TEL peak were found to be 4.48 and capacity factors were found to be 0.21 and 0.74 for BEN and TEL, respectively.
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来源期刊
SEPARATION SCIENCE PLUS
SEPARATION SCIENCE PLUS CHEMISTRY, ANALYTICAL-
CiteScore
1.90
自引率
9.10%
发文量
111
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