DOI: 10.21276/ajptr
Tue, 19 Feb 2019

Low level determination of Genotoxic impurities in Pimobendan drug by RP-HPLC

N. Gayatri Devi1, K. Bala Murali Krishna1, K. Geetha Bhavani2, B. Hari Babu1, D. Ramachandran1*

1.Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, A.P., India

2.Department of Chemistry, JMJ College for women, Tenali, A.P., India


(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.

Keywords: Pimobendan; Genotoxic; (6-(3, 4-diaminophenyl)-5-methyl-4,5-dihydro-pyridazine-3(2H)-one and p-anisaldehyde; RP-HPLC.

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