Abstract
STABILITY INDICATING HIGH PERFORMANCE THIN LAYER LIQUID CHROMATOGRAPHIC (HPTLC) METHOD FOR QUANTITATIVE ESTIMATION OF AMLODIPINE AND LISINOPRIL IN PHARMACEUTICAL FORMULATIONS

A. Ramyasree* and S. Sasi Mounika

ABSTRACT

Amlodipine (AM) and Lisinopril (LS) are used to treat hypertension. A simple, selective and stability indicating high performance thin layer chromatography (HPTLC) method has been established for analysis of AM, LS and their degradation products. Pre-coated silica gel 60F-254 TLC plates were used for the separation. n-Butanol: acetic acid: water (6:2:2 v/v/v) was optimized for the separation and determination of both drugs and the degradation products. Densitometric analysis of both drugs was carried out in absorbance mode at 560 nm. This system was found to give compact bands for AM and LS at Rf 0.69 and Rf 0.31 respectively. Linear relationships were obtained between response and amount of drug in the range 50-700 ng per band with high correlation coefficients. The method was validated for precision, robustness, and recovery. The limits of detection and quantitation were 20 and 50 ng per band (AM), 25 and 100 ng per band (LS), respectively. AM and LS were subjected degradation by acid (0.1N HCl), base (0.1N NaOH), oxidation (3%H202), dry heat, photo-light and ultraviolet. The degradation products were resolved from the pure drug with significantly different Rf values. Because the method could effectively separate the drug from its degradation products, it can be used for stability-indicating analysis.

Keywords: high performance thin layer chromatography, amlodipine(AM), lisinopril (LS), pharmaceutical formulations.


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