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Validation of Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry Coupled with Electrospray Ionization Method for Quantitative Determination of Ornidazole in Solid Dispersion

Author(s):

Gopal Prasad Agrawal*, Rajesh Kumar Maheshwari and Pradeep Mishra   Pages 1 - 6 ( 6 )

Abstract:


Background and Objective: The present study describes the UPLC-MS/MS method validation for the analysis of ornidazole in solid dispersion. Method: The proposed UPLC-MS/MS method utilizes BEH Shield RP18 column (2.1mm 100 mm, 1.7μm) with a gradient programmed mobile phase composed of water and acetonitrile at a flow rate of 0.4mL/min which varies with time program. Ornidazole was detected by UPLC-MS/MS with three proton adducts at m/z 82.04, 128.05 as daughter ions and 220.03 as a parent ion in multiple reaction monitoring (MRM) operated in positive mode. Result: Adducts at m/z 128.05 were found to be the most stable and showed higher intensity was selected for quantification of ornidaozle in solid dispersion. In the method, validation linearity was determined at a concentration range of 10–100ng/mL and a correlation coefficient was found (r2) ≥0.9994. The limit of detection and limit of quantification were found to be 2.7 and 10.0ng/mL, respectively. Inter and Intra-day precision was found within 0.33 and 0.11% and accuracy within 100.08% and 100.04%. Conclusion: A sensitive and selective UPLC-MS/MS method had been validated for the analysis of ornidazole in solid dispersion. The proposed method of analysis of ornidazole in solid dispersion can be used in quality control laboratories.

Keywords:

UPLC-MS/MS, Ornidazole, Solid Dispersion, Method Validation, ESI, Hydrotropic Agents.

Affiliation:

Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Research, GLA University, 17 Km Stone, NH-2, Mathura-Delhi Road, P.O. Chaumuhan, Mathura-281406 (U.P.) , Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Research, GLA University, 17 Km Stone, NH-2, Mathura-Delhi Road, P.O. Chaumuhan, Mathura-281406 (U.P.), Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Research, GLA University, 17 Km Stone, NH-2, Mathura-Delhi Road, P.O. Chaumuhan, Mathura-281406 (U.P.)



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