Development and validation of RP-HPLC method for the estimation of nintedanib esylate in bulk and its formulation was written by Patil, Rohan S.;Mahajan, Moreshwar P.. And the article was included in Research & Reviews: A Journal of Pharmaceutical Science in 2018.Synthetic Route of C33H39N5O7S The following contents are mentioned in the article:
A review. A simple, precise, reliable, rapid and reproducible reversed-phase high performance liquid chromatog. method (RP-HPLC) method has was developed and validated for the estimation of Nintedanib Esylate. Chromatog. was carried out with anal. technol. HPLC system consisted of UV-3000-M detector on C18 (4.6×250 mm, 5μ) column with a mobile phase composed of methanol:water (80:20 volume/volume) at a flow rate of 1 mL/min. The pH of the mobile phase was adjusted by 0.05% ortho phosphoric acid (pH-3). Detection was carried out using a UV detector at 287 nm. Parameters such as linearity, precision, accuracy, ruggedness, robustness, LOD and LOQ were studied as per the ICH Q2 (R1) guidelines. The retention time was found to be 4.67 min. The linearity range for Nintedanib esylate was 10-60μg/mL. The correlation coefficient was found to be 0.999. Developed method was found to be accurate, precise, selective and rapid for estimation of Nintedanib esylate in pharmaceutical dosage form. The proposed method can be useful in quality control of bulk manufacturing and pharmaceutical dosage form. 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: 656247-18-6Synthetic Route of C33H39N5O7S).
(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. Simple N-substituted piperazines have been found in many drug molecules. Although many piperazine derivatives occur naturally, piperazine itself can be synthesized by reacting alcoholic ammonia with 1,2-dichloroethane, by the action of sodium and ethylene glycol on ethylene diamine hydrochloride, or by reduction of pyrazine with sodium in ethanol.Synthetic Route of C33H39N5O7S
Referemce:
Piperazine – Wikipedia,
Piperazines – an overview | ScienceDirect Topics