The novel analytical method development and validation for related substances of Nintedanib Esylate by RP-HPLC method was written by Parmar, Yogendra B.;Shah, Dharmesh;Majmudar, Yashraj A.;Kaka, Ketul C.;Patel, Arpan S.;Kankad, Pankaj D.;Sartanpara, Uday G.. And the article was included in World Journal of Pharmaceutical Research in 2021.Safety of (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate The following contents are mentioned in the article:
An accurate, sensitive and rapid gradient reverse phase high performance liquid chromatog. (RP-HPLC) method has been developed and validated for related substances of Nintedanib Esylate. HPLC anal. was performed on YMC Triart, C18 (250 × 4.6) mm, 3μm. Column temperature maintained at 35°C conditions. Chromatog. separation was achieved with mobile phase gradient program at flow rate of 1.0mL/min. The injection volume was 10μl. The UV detection wavelength was 245nm. The method suitability was checked and validated according to the ICH guidelines Q2 (R1) for specificity, linearity, accuracy, precision, limit of quantification, limit of detection. Limit of detection of each impurity was found to be less than 0.031% weight/weight indicating that the developed method is highly sensitive. The calibration curve of each impurity was found to be linear within the concentration range of about 0.10μg/mL to 2.0μg /mL. The regression data for calibration curve shows good linear relationship. Correl coefficient (r2) of each impurity was found to be greater than 0.998. The Recovery was found to be accurate for each impurity within the spike concentration range of about 0.10μg/mL to 1.5μg /mL. The Recovery of each impurity was found to be between 80% to 120%. The experiment results are given in detail in this research article. This study involved multiple reactions and reactants, such as (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate (cas: 656247-18-6Safety of (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate).
(Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate (cas: 656247-18-6) belongs to piperazine derivatives. Piperazine was first introduced as an anthelmintic in 1953. Piperazine compounds mediate their anthelmintic action by generally paralyzing parasites, allowing the host body to easily remove or expel the invading organism. Piperazine is formed as a co-product in the ammoniation of 1,2-dichloroethane or ethanolamine. These are the only routes to the chemical used commercially.Safety of (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate
Referemce:
Piperazine – Wikipedia,
Piperazines – an overview | ScienceDirect Topics