DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF VALSARTAN
Keywords:
Valsartan, Stability Studies, Stability Indicating RP-HPLC, Stress Degradation, ICH GuidelinesAbstract
Objective: A stability indicating RP-HPLC method was developed and validated for the determination of Valsartan using Telmisartan (10 µg/ml) as the internal standard.
Methods: In this procedure Phenomenex ODS C-18(250×4.6 mm, packed with 5 micron) column was used with a new mobile phase consisting of methanol: acetonitrile: water (70:15:15 v/v) and the pH was adjusted to 3 by 0.1% glacial acetic acid with a flow rate of 1 ml/min. The eluents were monitored at 249 nm. Valsartan was subjected to stress conditions including hydrolytic degradation in acidic, basic and neutral conditions, oxidation, photolytic, UV degradation and thermal degradation.
Results: Linearity was obtained in the concentration range of 10-90 µg/ml (R2 =0.999) and with a regression equation y=0.074x+0.005. The LOD and LOQ values were 0.261 and 0.791 µg/ml respectively. The drug had shown promising degradation in the acidic, basic, neutral, thermal and oxidative stress conditions.
Conclusion: The method was validated for accuracy, precision, linearity, specificity and robustness and revealed that it is specific, accurate, rapid, precise, reliable and reproducible enough to analyze commercial dosage forms as per ICH guidelines.
Downloads
References
Blake PS. Cardiovascular drugs. In: Brayfield; Alison. editors. Martindale the complete drug reference. 33rd ed. London: Pharmaceutical Press; 2002. p. 853.
Tripathi KD. Essentials of medical pharmacology. New Delhi: Jaypee Brothers Medical Publishers; 2008. p. 875.
Krishnaiah C, Reddy AR, Kumar R, Mukkanti K. Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms. J Pharm Biomed Anal 2010;53(3):483–9.
Koseki N, Kawashita H, Hara H, Niina M, Tanaka M, Kawai R. Development and validation of a method for quantitative determination of valsartan in human plasma by liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal 2007;43:1769–74.
Rizzo M, Ventrice D, Casale F, Caselli GF, Makovec F. Pharmacokinetic study of a new angiotensin-AT1 antagonist by HPLC. J Pharm Biomed Anal 2008;48:422–7.
Shah NJ, Suhagia BN, Shah RR, Patel NM. Development and validation of HPTLC method for the simultaneous estimation of Valsartan and hydrochlorothiazide in tablet dosage form. Indian J Pharm Sci 2009;71(1):72–4.
Uttamrao KS, Bhatia MS. Validation of Valsartan and its degradation products by HPLC. J Chem Metrol 2010;3(1):1-12.
Chitlange SS, Bagri K, Sakarkar DM. Stability indicating RP-HPLC method for simultaneous estimation of Valsartan and Amlodipine in capsule formulation. Asian J Res Chem 2008;1(1):15-8.
Daneshtalab N. High-performance liquid chromatographic analysis of angiotensin II receptor antagonist valsartan using a liquid extraction method. J Chromatogr B 2002;76(6):345–9.
Sibel A, Ozakan SE, Gorger N, Altinay S, Zuhre S. Simultaneous determination of valsartan and hydrochlorthiazide in tablets by first-derivative UV spectrophotometry and LC. J Pharm Biomed Anal 2001;25(5):1009-13.