Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms

Journal of Pharmaceutical and Biomedical Analysis

Volumn 53, Issue 3, 2010, Pages 483-489

  Krishnaiah, Ch ^a,b   Reddy, A Raghupathi ^a   Kumar, Ramesh ^a   Mukkanti, K ^b  

^a DR REDDY'S LABORATORIES LTD   (India)

^b JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY   (India)

Author keywords

Forced degradation; Stability indicating; UPLC; Validation; Valsartan

Indexed keywords

PLACEBO; VALSARTAN;

ACCURACY; ACIDITY; ALKALINITY; ARTICLE; CONTROLLED STUDY; DRUG DEGRADATION; DRUG IMPURITY; DRUG PURITY; DRUG STABILITY; ELUTION; HYDROLYSIS; OXIDATION; OXIDATIVE STRESS; PHOTOLYSIS; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SENSITIVITY AND SPECIFICITY; TABLET; TEMPERATURE STRESS; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDATION STUDY;

ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DOSAGE FORMS; DRUG STABILITY; LIMIT OF DETECTION; TETRAZOLES; VALINE;

EID: 77954862332     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.05.022     Document Type: Article

References (16)

1. Francotte E., Davatz A., Richert P. Development and validation of chiral high-performance liquid chromatographic methods for the quantitation of valsartan and of the tosylate of valinebenzyl ester. J. Chromatogr. B: Biomed. Appl. 1996, 686:77-83.
2. Piao Z.Z., Lee E.S., Tran H.T., Lee B.J. Improved analytical validation and pharmacokinetics of valsartan using HPLC with UV detection. Arch. Pharm. Res. 2008, 31:1055-1059.
3. Iriarte G., Ferreiros N., Ibarrondo I., Alonso R.M., Itxaso Maguregui M. Biovalidation of an SPE-HPLC-UV-fluorescence method for the determination of valsartan and its metabolite valeryl-4-hydroxy-valsartan in human plasma. J. Sep. Sci. 2007, 30:2231-2240.
4. Sampath A., Raghupathi Reddy A., Yakambaram B., Thirupathi A., Prabhakar M., Pratap Reddy P., Prabhakar Reddy V. Identification and characterization of potential impurities of valsartan AT1 receptor antagonist. J. Pharm. Biomed. Anal. 2009, 50:405-412.
5. Zhang D., Du X., Liu M., Li H., Jiang Y., Zhao L., Gu J. Determination of ecabet in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2008, 863:223-228.
6. Macek J., Klima J., Ptacek P. Rapid determination of valsartan in human plasma by protein precipitation and high-performance liquid chromatography. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2006, 832:169-172.
7. Ferreiros N., Iriarte G., Alonso R.M., Jimenez R.M., Ortiz E. Separation and quantitation of several angiotensin II receptor antagonist drugs in human urine by a SPE-HPLC-DAD method. J. Sep. Sci. 2008, 31:667-676.
8. Zarghi A., Shafaati A., Foroutan S.M., Movahed H. Rapid quantification of valsartan in human plasma by liquid chromatography using a monolithic column and a fluorescence detection: application for pharmacokinetic studies. Sci. Pharm. 2008, 76:439-450.
9. Panderi I.E., Parissi P.M. Simultaneous determination of benazepril hydrochloride and hydrochlorothiazide by micro-bore liquid chromatography. J. Pharm. Biomed. Anal. 1999, 21:1017-1024.
10. Farthing D., Fakhry I., Ripley E.B., Sica D. Simple method for determination of hydrochlorothiazide in human urine by high performance liquid chromatography utilizing narrowbore chromatography. J. Pharm. Biomed. Anal. 1998, 17:1455-1459.
11. Richter K., Oertel R., Kirch W. New sensitive method for the determination of hydrochlorothiazide in human serum by high-performance liquid chromatography with electrochemical detection. J. Chromatogr. A 1996, 729:293-296.
12. Prasad C.V., Parihar C., Sunil K., Parimoo P. Simultaneous determination of amiloride HCl, hydrochlorothiazide and atenolol in combined formulations by derivative spectroscopy. J. Pharm. Biomed. Anal. 1998, 17:877-884.
13. Shah N.J., Suhagia B.N., Shah R.R., Patel N.M. HPTLC method for the simultaneous estimation of valsartan and hydrochlorothiazide in tablet dosage form. Indian J. Pharm. Sci. 2009, 71:72-74.
14. Kocyigit-Kaymakcoglu B., Unsalan S., Rollas S. Determination and validation of ketoprofen, pantoprazole and valsartan together in human plasma by high performance liquid chromatography. Pharmazie 2006, 61:586-589.
15. ICH Q1A (R2), Stability Testing of New Drug Substances and Products, 2000.
16. ICH Q2 (R1), Validation of Analytical Procedures: Text and Methodology, 2005.