Abstract
DETERMINATION AND QUANTIFICATION OF A 1-BENZHYDRYL-4-NITROSOPIPERAZINE IN THE CINNARIZINE ACTIVE PHARMACEUTICAL INGREDIENT BY LC-MS/MS

Vinayak T. Vele*, Kishor More, Mohan A. Chandavarkar, Shivaji Kadam, Sushil Singh, Amol Kumbhar

ABSTRACT

A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the quantification of 1-benzhydryl-4-nitrosopiperazine in the Cinnarizine active pharmaceutical ingredient. Chromatographic separation was achieved using a Waters Acquity HSS T3 C18 column, with 0.1% formic acid in water as mobile phase A and acetonitrile as mobile phase B in gradient elution mode at a 0.25 ml/ min flow rate. Quantification of impurities was carried out using triple quadrupole mass detection with electrospray ionization in the multiple reaction monitoring mode. The method was validated with good linearity over the concentration range of 0.02-0.30 ppm of the Cinnarizine test concentration for 1-benzhydryl-4-nitrosopiperazine. The correlation coefficient obtained in each case was >0.9990. The recoveries were found to be satisfactory over the range between 80.0 and 120.0 % for 1-benzhydryl-4-nitrosopiperazine. The developed method was able to quantitate 1-benzhydryl-4-nitrosopiperazine at a concentration level of 0.6 ng mL-l (0.02ppm with respect to 30 mg mL-1 Cinnarizine).

Keywords: Nitrosamine, 1-benzhydryl-4-nitrosopiperazine, LCMS/MS, Validation, Cinnarizine.


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