Separation of Etoricoxib and Its Degradation Products in Drug Substance Using UPLCTM
Dinesh N. Vora 1  
,  
 
 
More details
Hide details
1
Chemistry Dept. Mithibai College of Arts, Chauhan Institute of Science & A.J. College of Commerce and Economics, Vile Parle (W), Mumbai – 400 056, Maharashtra, India
Publish date: 2017-10-04
 
Eurasian J Anal Chem 2007;2(3):151–158
KEYWORDS:
ABSTRACT:
A UPLCTM method was developed and validated for the separation of Etoricoxib and its degradation products in drug substance. The main drug and its seven major and few minor degradation products were well separated within seven minutes on acquity UPLCTM BEH C18 column (1.7 µ, 2.1 x 100 mm) maintained at 25°C, using 0.01M acetate buffer pH 5.0 - acetonitrile (60 : 40, v/v) as mobile phase. The flow rate was 0.3 mL.min-1 and observed backpressure was about 10500 psi. Detection was performed at 235 nm using PDA detector. Linearity was obtained in the concentration range of 0.05 - 120 µg.mL-1. The method was validated for precision, linearity, LOD and LOQ. Stability indicating capability was established by forced degradation experiments.
CORRESPONDING AUTHOR:
Dinesh N. Vora   
Chemistry Dept. Mithibai College of Arts, Chauhan Institute of Science & A.J. College of Commerce and Economics, Vile Parle (W), Mumbai – 400 056, Maharashtra, India
 
REFERENCES (9):
1. Matthews C Z, Subramanian R, Woolf E J, Foster N, Matuszewski B K (2004) Isolation and structural characterization of the photolysis products of Etoricoxib. Pharmazie 59: 913.
2. Ramakrishna N V, Vishottam K N, Wishu S, Koteshwara M (2005) Validated liquid chromatography method for the quantitation of etoricoxib in human plasma using liquid liquid extraction. J. Chromatogr B Analyt Technol Biomed Life Sci. 816: 215.
3. Liberato B Jr, Danieli C C, Marcio F, Paulo R, Sergio D (2003) Validation of an LC tandem MS/MS method for the determination of etoricoxib in human plasma and pharmaceutical formulations. J Liq Chromatogr Relat Technol 29: 123.
4. Liberato B Jr, Danieli C C, Marcio F, Thiago B, Sergio L D (2006) Validation of liquid chromatography and liquid chromatography tandem mass spectrometry methods for the determination of etoricoxib in pharmaceutical formulations. J AOAC Int 89: 1268.
5. Ansari T A, Jamil S, Singh R M, Mathur S C, Shivraj, Singh G N (2005) Determination of etoricoxib in bulk drug and its dosage forms by RP-HPLC. Indian Drugs. 42: 56.
6. Robert H, Ahmed A, Andrew C, Bing M, Louis S C, Zhihong G (2005) Development and validation of an HPLC method for the impurity and quantitative analysis of etoricoxib. J Liq Chromatogr Relat Technol 26: 2551.
7. Wren S, Tchelitcheff P (2006) Use of UPLC in pharmaceutical development. J Chrom A 1119: 140.
8. Novakova L, Matysova L, Solich P (2006) Advantages of application of UPLC in pharma analysis. Talanta 68:908.
9. International Conference on Harmonization (ICH), Q2 (R1) (2005) Validation of analytical procedures: Text and methodology.
eISSN:1306-3057