Objective: The study of present work is to develop and validate a method which is new rapid,
simple, sensitive, accurate, economical and specific isocratic RP-HPLC for the determination of
related substances in bulk form of Ketobemidone.HCl which is used as Opioid analgesic for
various class of ascetic pains such as post-operative, stones in kidney, cancer and fractures.
Results: Chromatographic separation was carried out isocratically with Waters Alliance 2695
model pump with 2998 PDA detector with wavelength of 280nm, luna phenyl hexyl 250x4.6mm.
Mobile phase is prepared by using buffer: acetonitrile in the ration of 80:20. Rate of flow was
adjusted to 1.5ml/min which gave well separated peaks with good time intervals. The developed
method is then validated for precision, linearity accuracy, Limit of Quantification and Limit of
detection, robustness. The Limit of detection values of Ketobemidone.HCl. Impurity A, B, C, D
are 0.001, 0.001, 0.001, 0.001, 0.003. The Limit of Quantification values of Ketobemidone.HCl,
Impurity A, B, C, D are 0.003, 0.003, 0.002, 0.004, 0.01.The correlation coefficient value of
Ketobemidone.HCl is (R) = ? 0.95 and its impurities was found to
0.9988,0.9938,0.9958,0.9938.The accuracy of Ketobemidone. HCL was found to be % Relative
Publication date: 01/12/2023
https://ijbpas.com/pdf/2023/December/MS_IJBPAS_2023_7650.pdf
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https://doi.org/10.31032/IJBPAS/2023/12.12.7650
