European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT OF STABILITY INDICATING ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF EZETIMIBE AND GLIMEPIRIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Varsha Mandawad and Padmanabh B. Deshpande*

ABSTRACT

A simple, accurate, precise and selective stability indicating High performance thin layer chromatography method was developed and validated for the simultaneous quantitative analysis of Ezetimibe and Glimepiride in combined pharmaceutical dosage form. Degradation studies were carried out by subjecting both the drugs to different stress conditions as recommended by the International Conference on Harmonization (ICH). Stability indicating high performance thin layer chromatographic method for ezetimibe and glimepiride estimation was developed by using the degraded samples. The acceptable resolution of two drugs from their degradation products was achieved with the use of precoated silica gel 60 F254 aluminium plates as stationary phase and Toluene: Methanol: Acetone: Triethylamine (7: 2: 1: 0.2, v/v/v) as optimum mobile phase. Densitometric detection was carried out at 246 nm. The retention factors were found to be 0.28 ± 0.03 for ezetimibe and 0.60 ± 0.001 for glimepiride. The developed method was validated for linearity, precision, accuracy, specificity and robustness. The results demonstrated that the described method was suitable for quantitative analysis of ezetimibe and glimepiride in the presence of their degradation products formed under a variety of stress conditions. The proposed method will be applicable to the determination of stability of ezetimibe and glimepiride drugs and can be successfully used in quality control of bulk manufacturing and pharmaceutical preparations.

Keywords: Glimepiride, Ezetimibe, Stability studies, Method validation.