STABILITY INDICATING HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY FOR CARVEDILOL IN BULK DRUG AND IN SOLID LIPID NANOPARTICLESAbstract
A stability indicating high-performance thin-layer chromatographic method (HPTLC) was developed and validated as per the International Conference on Harmonization (ICH) guidelines for determination of carvedilol (CRL) both in bulk drug and solid lipid nanoparticles (SLNs). The solvent system comprised of toluene–chloroform-methanol-acetic acid (2.0:2.0:1.0:0.04, v/v/v), gave compact spot of CRL at Rf 0.56 ± 0.05. The spectrodensitometric analysis was performed at 242 nm. The linear graph upon regression analysis showed r2 = 0.998 with respect to peak area at the concentration range of 50–1000 ng spot−1. The limit of detection and quantification was found to be 7.9 and 24.2 ng spot-1, respectively. The drug was subjected to stress conditions like acid and alkali hydrolysis, oxidation, photo degradation, dry as well as wet heat treatment and evaluated for stability and degradation product. The acidic and alkaline degradation kinetics was also studied using developed HPTLC method. SLNs were developed using hot melt technique and subjected stability testing along with commercial tablet.
M.S. Faisal*, Z. Naz, M. Sawan, M. H. Akhter, J. Ali, F. Shakeel and S. Baboota
Department of Pharmaceutics, College of Pharmacy, Al-asmarya University, Zliten, Libya.
14 January, 2017
08 May, 2017
14 May, 2017
31 May, 2017