Validated High-Performance Liquid Chromatographic andChemometric Based Spectrophotometric Determination of Ramipril and Atorvastatin in Pharmaceutical Dosage Forms

Nagaraj Gowda ； Raju Tekal ； Radhasri Thangavelu ； Kalamkar Vipul ； Mashru Rajashree

《藥物食品分析》 20卷3期 (2012/09) Pp. 577-587

https://doi.org/10.6227/jfda.2012200303

並列摘要

A fast, simple RP-HPLC and three spectrophotometric methods based on classical least squares (CLS), principle component regression (PCR) and pania11east squares (PLS) calibrations were developed for sitmultaneous estimation of ramipril (RAMP) and atorvastatin calcium (ATOR) in formulations. The HPLC assay utilized Phenomenex-Luna RP C-18 (2) 250 x 4.6 mm 5μm column with mobile phase composition of acelonitrile: 0.1M sodium perchlorate (pH 2.5) (70:30, v/v), and flow rate of 1.5mL/min with UV detection at 210nm. Chcmometric calibrations were constructed by using absorption data matrix corresponding to concentration data matrix, with measurements in the range of 201-270nm (Δλ= 1nm) in their zero-order spectra using 25 samples in training set. The chemometric numerical computations were realized using novel R-Software Environment (version 2.1.1). Reliability of predictions was validated for various ICH regulatory parameters. Both the results of proposed chemometric methods and that of proposed chromatographic method were compared and good agreement was found. Laboratory prepared mixtures and commercial tablet formulations were successfully analyzed by the developed methods.

並列關鍵字

CLS ； PCR ； PLS ； R-software environment ； RP-HPLC

參考文獻

Campbell, D. J., Kladis, A. and Duncan, A. M. 1993. Nephrectomy, converting enzyme inhibition and angiotensin peptides. Hypertension 22: 513-522.

Nawrocki, J. W., Weiss, S. R., Davison, M. H., Sprecher, D. L., Schwarts, S. L., Lupien, P. J., Jones, P. H., Habert, H. E. and Black, D. M. 1995. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arterioscler. Thromb. Vasc. Biol. 15: 678-682.

Lea, A. P. and Tavish, D. M. 1997. Atorvastatin: a review of its pharmacology and therapeutic potential in the management of hyperlipidemias. Drugs 53: 828-847.

Chiong, J. R. and Miller, A. B. 2002. Renin-angiotensin system antagonism and lipidlowering therapy in cardiovascular risk management. J. Renin Angiotensin Aldosterone Syst. 3: 96-102.

Pizzi, C., Manfrini, O., Fontana, F. and Bugiardini, R. 2004. Angiotensin-converting enzyme inhibitors and 3-hydroxy-3-methylglutaryl coenzyme A reductase in cardiac syndrome X: role of superoxide dismutase activity. Circulation 109: 53-58.