Comparative Study of Forced Degradation Behavior of Telmisartan by UPLC and HPLC and Development of Validated Stability Indicating Assay Method According to ICH Guidelines

Abstract

A novel comparative force degradation ultra-performance liquid chromatographic assay method was developed and validated for Telmisartan and its degradation products. Telmisartan was subjected to acid (0.1M HCl), neutral (water) and alkaline (0.1M NaOH) hydrolytic conditions at 80°C, as well as to oxidative decomposition (H2O2) at room temperature. Photolytic studies were carried out by exposing this drug into sunlight (60,000-70,000 lux) for 2 days. Additionally, the solid drug was subjected to 50°C for 60 days in a hot air oven for thermal degradation. The UPLC chromatographic separation was performed on Acquity UPLC BEH C18 column (1.7 μm, 2.1mm×150mm) using isocratic mode (ACN:water, 70:30v/v) at flow rate of 0.2 ml min-1 and HPLC chromatographic separation was achieved on phenomenex C18 using isocratic mode (ACN:10mM ammonium acetate, Ph 4.5, 85:15v/v) at flow rate of 1.0 ml min-1. Telmisartan was found to degrade significantly in acid, base and oxidation, the drug was found to be stable in neutral, thermal and photolytic stress conditions. The ultra performance liquid chromatography (UPLC) and high performance liquid chromatography (HPLC) area %RSD were calculated to be 0.0039 and 0.0015 respectively. The UPLC and HPLC linearity of the proposed method were investigated in the range of 10-50 μg mL-1 and 30-150 μg mL-1 . The r2 value of UPLC and HPLC were found to be 0.9987 and 0.9989 respectively. Method detection limit (MDL) and Method quantification limit (MQL) were found to be 0.250 μg mL-1 and 1.20 μg mL-1 for UPLC and 0.600 μg/ml and 1.900 μg mL-1 respectively for HPLC. The %R.S.D. values for intra-day and inter-day precision were <1.0%, confirming that the method was sufficiently precise. The validation studies were carried out fulfilling ICH requirements. The developed method was simple, fast, accurate and precise and hence could be applied for routine quality control analysis of Telmisartan in solid dosage forms.