Determination of Oxazolidinone Impurity in Ritonavir and Lopinavir Tablet Formulation by Using RP-LC Technique

International Journal of Applied Chemistry

© 2022 by SSRG - IJAC Journal

Volume 9 Issue 1

Year of Publication : 2022

Authors : Y.S.R.V.S Jogarao, Ponnuri Bharath, V. Siva Ramakrishna, D. Ramachandran

10.14445/23939133/IJAC-V9I1P102

How to Cite?

Y.S.R.V.S Jogarao, Ponnuri Bharath, V. Siva Ramakrishna, D. Ramachandran, "Determination of Oxazolidinone Impurity in Ritonavir and Lopinavir Tablet Formulation by Using RP-LC Technique," SSRG International Journal of Applied Chemistry, vol. 9,  no. 1, pp. 10-17, 2022. Crossref, https://doi.org/10.14445/23939133/IJAC-V9I1P102

Abstract:

A highly sensitive method for the determination of oxazolidinone impurity in Ritonavir tablet formulations using RP-HPLC has been presented in the present paper. Quantification of oxazolidinone impurity content in Ritonavir tablet formulation samples by HPLC with UV Detector. Oxazolidinone was determined by the RP-HPLC method using YMC Pack ODS-AQ (150 x 4.6mm, 3μm) column as stationary phase. The mobile phase consisted of phosphate buffer, acetonitrile, methanol and tetrahydrofuran in the ratio of 625:175:100:100 v/v/v/v is used as Mobile phase-A and phosphate buffer, acetonitrile, methanol and tetrahydrofuran in the ratio of 400:200:200:200 v/v/v/v used as Mobile Phase-B, with the help of the gradient elution. Column temperature maintained 40°C and sample cooler temperature 25°C, Injection volume 50μL, the Flow rate was 1.5 ml/min and the separated oxazolidinone was detected using UV detector at the wavelength of 240 nm and run time was 45mintues. The method validation has been carried out as per International Conference on Harmonization guidelines (ICH). Limit of quantitation (LOQ) was found 0.24ppm for oxazolidinone.

Keywords:

Oxazolidinone impurity, Ritonavir tablet formulation, RP-LC method, validation and limit of quantitation.

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