Commercially viable manufacturing process for Flecainide Acetate (I) conforming to regulatory specification and cost effective process is reported. Specifically, an improved process for the preparation of Flecainide Acetate allows isolation of anhydrous hydrochloride salt of Compound III, which facilitates the reduction of the pyridine ring with the only catalytic amount of platinum on carbon within 2 hours Therefore, simplifies the synthesis and isolation of Flecainide acetate on a commercial scale to a considerable extent.
The improved synthesis of Flecainide acetate (I) is conferred in this article. The chief intent to present this article is to identify and synthesis of the process related impurities of Flecainide acetate.
The article also provides the complete study and characterization of the process impurities. Most of the impurities are the in-situ generated intermediates which are tend to carryforward to the final step of synthesis. The more interesting part is the formation of 2,5 –bis (2,2,2-trifluoroethoxy)-N-((4-methylpiperidine-2-yl) methyl) benzamide impurity during Flecainide acetate synthesis.
The article confers the synthesis of 2,5 –bis (2,2,2-trifluoroethoxy)-N-((4-methylpiperidine-2-yl) methyl) benzamide and its control in Flecainide acetate.
The quantitative analysis method for the quantitative analysis of the anti-histaminic drug Promethazine Hydrochloride (PMZ•HCl) is stated by a straightforward, smooth, reliable and reverse step of the ultra-performing liquid chromatographic method (RP-UPLC). Following ICH quidelinesQ2(R1), the RP-UPLC method has been developed and checked. The uniform solution of 3.4% KH2PO4 solution in water, 7.0 pH with dilute KOH, ACN, andMeOH in ratio of 40:40:20, used as a mobile phase. The flow of 0.6 mL/minusing photo diode array detector / UV detector by with wavelength of 254 nm and runtime 3 min. This gives linearty from 80-120 % with correlation coefficient of 0.99988. Repeatability and intermediate precision shows relative standard deviation (percent RSD) of 0.52, 0.24 and a overall RSD of 0.43. Robustness studies show no indicative changes in SST requirements, like asymmetry factor, theoretical plate & percentage relative standard deviation. These criteria's values are well within their acceptability limit. The degradation of promethazine under different stress conditions has been studied and shows that all known impurities and degradants are well separated from promethazine peak.This RP-UPLC is descriptive and accurate.
The Pharmaceutical industry uses formic acid in the manufacturing of various drug substances or API. At the time of manufacturing of API formic acid is use as an oxidizing agent. Formic acid is the simplest carboxylic acid. It also called methanoic acid.Formic acid present in API at high concentrations is very hazardous but in low concentrations is very beneficial. The developed and validated method was short, precise, cost effective and reproducible with FID detector and easy to use. The method is a selective and superficial analytical method for determination of formic acid in different drug substances. We report here the development and validation study of headspace gas chromatographic method to determine formic acid in different drug substances we are reported here. As per this method, the drug sample was dissolved in 0.1% (v/v) of concentrated sulfuric acid in isopropyl alcohol (IPA) in a GC headspace vial and 0.1% (v/v) of concentrated sulfuric acid in isopropyl alcohol used as a diluent. A AB-Inowax capillary column (30 m x 0.32 mm I.D. and 0.5 µm film thickness) was used under gradient conditions with FID. The formic acid peak was well separated from all other solvents that are used in synthesis of particular drug substance. The LOD and LOQof the method for formic acid are 82 ppm and 249 ppm respectively. Formic acid are low toxic class-III solvent as per ICH guideline.
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