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THE PHARMA REVIEW (JULY AUGUST 2019)

Estimation of Clonixin in Human Plasma by using LC-MS-MS Technique

G. Raveendra Babu1, A. Lakshmana Rao2* & J. Venkateswara Rao3

Introduction: The present work describes development of liquid chromatography-mass spectrometry-mass spectrometry (LC-MS-MS) method for the determination of Clonixin in human plasma and validated. Clonixin and Flunixin were extracted with methanol and ammonium formate (70:30, v/v) by using liquid-liquid extraction technique. The chromatographic separation was achieved by using ACE C18 (50 mm X 4.6 mm, 5 μm particle size) column with a run time was 2 min. The LC-MS-MS system consists turbo ion spray of ion sources, API 4000 triple quadrupole mass analyzer, coupled with Shimadzu LC-20AD module pump. Acquire chromatograms using the analyst software version 1.4.2 was used. Validation parameters were checked like matrix effect, linearity, precision, lower limit of quantification and accuracy attained the acceptance criteria as per ICH guidelines. Clonixin has determined by various stability studies, like short term stability for 9 hours at 240C, long term stability for 7 days, 4 hours at 2-80C, dry extract stability for 21 hours, 42 minutes at 240C, auto sampler stability for 45 hours, 30 minutes at 100C, bench top stability for 8 hours, 36 minutes and freeze thaw stability at -700C for five cycles were found in human plasma. The present method is simple, sensitive, rapid, precise and more accurate for determination of Clonixin in human plasma by using LC-MS-MS has been adopted for bio-analytical and bioequivalence studies of Clonixin sample solutions.

 

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