N. Gayatri Devi

A new simple, accurate, rapid and precise isocratic RP-HPLC was developed and validated for the determination of Rosuvastatin and Ezetimibe in Pharmaceutical tablet dosage form by droping method. The Method employs Shimadzu LC system on Hypersil ODS column (4.6 x 250 mm, 5 µm) and flow rate of 1.5ml/min with an injection volume 20µl.  Buffer, Acetonitrile and Methanol was used as mobile phase in the composition of 40:30:30v/v. The Detection was carried out at 230nm. Linearity ranges for Rosuvastatin and Ezetimibe were 11-33µg/ml, 10-30µg/ml respectively for HPLC. Retention Time of Rosuvastatin and Ezetimibe were found to be 3.7 and 5.7 min respectively. Percent Recovery study values of Rosuvastatin and Ezetimibe were found 99.6-101.1% and 99.9-100.7% respectively. This newly developed method i.e. droping method was successfully utilized for the Quantitative estimation of Rosuvastatin and Ezetimibe in tablet dosage form. This method was validated for selectivity, accuracy, precision, and linearity, Ruggedness, Robustness and Stability Studies as per ICH guidelines.

(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.