作者
KP Pandey, CL Singh, Smita Verma, A Singh, Roopali Jha, O Porwal, N Fuloria, PK Sharma
发表日期
2022/3/1
期刊
Indian Journal of Pharmaceutical Sciences
卷号
84
期号
2
简介
In the present work high performance liquid chromatography method was developed and validated for imatinib mesylate and its related substances. The analyzed active pharmaceutical ingredient and its impurities were separated by Atlantis T3 (150 mm× 4.6 mm), 3 µm column with ultraviolet detection at 230 nm. The mobile phase has been used in specific composition (50: 50, v/v, organic and inorganic) that was prepared using methanol and buffer (0.01 M of 1-Octane sulphonic acid with 0.2% trifluoroacetic acid). The results of proposed method were analyzed and validated as per International council on harmonisation guidelines. The percentage relative standard deviation was observed as 1.15% for system precision that was found within the limit. The method was found to be specific as there was no interference between blank, imatinib mesylate and impurities. The limit of detection and quantitation was found 0 …
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