Stability Indicating HPTLC Method for Estimation of Nebivolol Hydrochloride and Amlodipine Besylate in Combination
Year: 2010
Type: article
Abstract: A sensitive, selective, precise and stability indicating high-performance thin-layer chromatographicmethod of analysis of Amlodipine besylate and Nebivolol hydrochloride both as a bulk drug and informulations containing these two in combination was developed and validated. The method employedTLC aluminum plates precoated with silica gel 60F254 as the stationary phase. The solvent systemconsisted of Ethyl acetate: Methanol: Dilute ammonia (8.5:1:1, v/v/v). This system was found to givecompact spots for Amlodipine besylate (Rf 0.40± 0.01) and Nebivolol hydrochloride (Rf 0.60 ± 0.02).Amlodipine besylate and Nebivolol hydrochloride were individually subjected to stress degradationconditions like oxidation, dry heat treatment, photo degradation and hydrolysis under different pH.The peaks of products formed during stress degradation studies were well resolved from the bulk drugpeak with significantly different Rf values. Densitometric analysis of Amlodipine besylate andNebivolol hydrochloride was carried out at 240 and 280 nm respectively. The linear regressionanalysis data showed good linear relationship in the concentration range 500–2000 ng spot -1 for bothAmlodipine besylate and Nebivolol hydrochloride. The method was validated for linearity, accuracy,specificity, LOD, LOQ, precision and robustness. The limits of quantitation for Amlodipine besylateand Nebivolol hydrochloride were found to be 313 and 277 ng spot -1 respectively. The statisticalanalysis proved that the method is repeatable and selective for the estimation of the said drugs. As themethod could effectively detect the drugs in the presence of their degradation products, it can beemployed as a stability indicating one.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W1792287285