K. Geetha Bhavani

(6-(3,4-diaminophenyl)-5-methyl-4,5-dihydropyridazine-3(2H)-one(GTI-A) and p-anisaldehyde (GTI-B)have been highlighted a (GTI's) potential genotoxic impurities (PGIs) of Pimobendan. A sensitive RP-HPLC method was developed and validated for the determination of (6-(3,4-diaminophenyl)-5-methyl-4,5-dihydropyridazine-3(2H)-one and p-anisaldehyde in pimobendan using Zodiac C18 (125 X 4.6mm 5µ) column, with UV Detector. The calibration curves showed good linearity over the concentration range of 0.5μg/mL to 1.5μg/mL with respect to the sample. The correlation coefficient was 0.999. Excellent recoveries of 102 % were obtained at the level of 0.5μg/mL.

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Curcumin in tablet formulations. The separation was achieved by using column Hypersil BDS C18, 150x4.6 mm, 5µ (Make: Thermo), in mobile phase consisted of tetrahydrofuran and citric acid buffer in the ratio of (550:450, v/v). The flow rate was 1.0 mL.min-1 and the separated curcumin was detected using UV detector at the wavelength of 425 nm. The retention time of curcumin, was noted to be 8.05 min respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.