Journal of Pharmacy And Bioallied Sciences

ORIGINAL ARTICLE
Year
: 2013  |  Volume : 5  |  Issue : 4  |  Page : 257--264

Bioanalytical method development and validation of alimemazine in human plasma by LC-MS/MS and its application in bioequivalence studies


Bhupinder Singh1, Sandeep Sharma1, Naveen Dubey1, Ashish Dwivedi1, Rama S Lokhandae2 
1 Bioanalytical Department, Jubiliant Clinsys Limited, Noida, New Delhi, India
2 School of Basic Sciences, Jaipur National University, Jaipur, Rajasthan, India

Correspondence Address:
Bhupinder Singh
Bioanalytical Department, Jubiliant Clinsys Limited, Noida, New Delhi
India

Background: The use of anti-histaminic agents has been increased significantly from last decades and till now no method is available for quantitation of ALZ in human plasma which can be applied in a bioequivalence study using LC-MS/MS. Objective: The present study is concerned with the development and validation of ALZ in human plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS). Materials and Methods: Sample preparation involved the extraction with liquid-liquid extraction method by using ethyl acetate as an organic solvent. Chromatographic separation was performed on Atlantis; T3 5 ΅m 4.6 mm Χ 150 mm column with the mobile phase consisting of acetonitrile: (10 mm ammonium formate buffer: Formic acid: 99.9:00.1 v/v) 50:50 v/v. The interface used with the application programming interface 4000 LC-MS/MS was a turbo ion spray in which positive ions were measured in multiple reaction monitoring mode. The precursor to product ions transition of m/z 299.30 → 100.20 amu and 305.30 → 106.30 amu were used for ALZ and ALZ D6 respectively. Results: The method was validated over the concentration range of 20.013-10006.551 pg/mL. The mean percent recovery of ALZ was found 77.771% with a precision of 7.71% and the lower limit of quantification was 20.013 pg/mL. The intra- and inter-day precision of the method at three concentrations was 0.98-4.50% and 1.57-5.72% while the intra- and inter-day % accuracy was 99.02-93.82% and 101.78-106.96%. Stability of compounds was established in a series of stability studies. The application of this method was demonstrated in the bioequivalence study and was found suitable in a study of sample size as big as 30 enrolled volunteers. Conclusion: For the very first time, a sensitive, selective and robust Liquid Chromatography- Mass Spectrometry method for the determination of alimemazine (ALZ) in human plasma has been developed and validated using ALZ D6 as an internal standard.


How to cite this article:
Singh B, Sharma S, Dubey N, Dwivedi A, Lokhandae RS. Bioanalytical method development and validation of alimemazine in human plasma by LC-MS/MS and its application in bioequivalence studies.J Pharm Bioall Sci 2013;5:257-264


How to cite this URL:
Singh B, Sharma S, Dubey N, Dwivedi A, Lokhandae RS. Bioanalytical method development and validation of alimemazine in human plasma by LC-MS/MS and its application in bioequivalence studies. J Pharm Bioall Sci [serial online] 2013 [cited 2020 Mar 31 ];5:257-264
Available from: http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2013;volume=5;issue=4;spage=257;epage=264;aulast=Singh;type=0