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 AJAC  Vol.5 No.5 , April 2014
Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography
Abstract: A simple, precise, accurate and sensitive reverse phase high performance liquid chromatographic method for simultaneous estimation of lisinopril dihydrate and its degradation products occuring under different ICH prescribed stress conditions has been modified. Drug was resolved on a C18 column, utilizing modified mobile phase of tetra butyl ammonium hydroxide solution and acetonitrile. Ultra violet detection was carried out at 210 nm. The method was modified with respect to linearity, precision, accuracy, selectivity, specificity and ruggedness. The results obtained revealed that lisinopril dihydrate was an active product slightly changed under stress conditions.
Cite this paper: Adam, E. (2014) Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography. American Journal of Analytical Chemistry, 5, 316-322. doi: 10.4236/ajac.2014.55039.
References

[1]   British Pharmacopeia (2010) Volume II. Lisinopril Dihydrate. 1279-1280.

[2]   United States Pharmacopeia 34-NF 29 (2011) Volume (3). Lisinopril dihydrate. USP-National Formulary Convention, Rockville, Maryland, 3320.

[3]   Lancaster, S.G. and Todd, P.A. (1988) Lisinopril. A Preliminary Review of Its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Use in Hypertension and Congestive Heart Failure. Drugs, 35, 646-669.
http://dx.doi.org/10.2165/00003495-198835060-00003

[4]   Sean, C.S. (2009) Lisinopril Dihydrate. 36th Edition, Royal Pharmaceutical Society of Great Britain (RPS) Publishing, Martindale, 1325-1326.

[5]   Simpson, K. and Jarvis, B. (2000) Lisinopril: A Review of Its Use in Congestive Heart Failure. Drugs, 59, 1149-1167.
http://dx.doi.org/10.2165/00003495-200059050-00012

[6]   Food and Drug Administration (FDA) (2000) Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation; Availability. Federal Register (Notices), 65, 52776-52777.

[7]   Food and Drug Administration (FDA) (1987) Guideline for Stability Studies for Human Biologics. Office of Drug Standards, New York, 3-10.

[8]   International Conference on Harmonization (ICH) (2003) Stability Testing New Drug Substance and Drug Products, Q1A [R2].

[9]   International Conference on Harmonization (ICH) (1996) Stability Testing: Photostability Testing of New Drug Substance and Drug Products, Q1B.

[10]   International Conference on Harmonization (ICH) (2003) Evaluation for Stability Data, Q1E.

[11]   Beckett, A.H. and Stenlake, J.B. (1988) Chromatography. Chapter Four. Practical Pharmaceutical Chemistry. Part One. Athlone Press, London, 115-128, 157-174.

[12]   Snyder, L.R. and Kirkland, J.J. (1997) Practical HPLC Method Development. Wiley Interscince, Chichester, London, 15-35.

[13]   Meyer, V.R. (1994) Practical High Performance Liquid Chromatography. J. Wiley and Sons, Chichester, London, 10-25.

[14]   Amin, M.I. and Bryan, J.T. (1973) Kinetic Factors Affecting Stability in Aqueous Formulation. Pharmacy Science, 62, 1768-1771.

 
 
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