Advanced forced degradation technique for simultaneous estimation of azelnidipine and telmisartan implementing AQbD approach in its tablet dosage form

Abstract

For simultaneous estimation of Azelnidipine and Telmisartan in pharmaceutical dosage form, a simple, rapid, precise and reproducible RP-HPLC method was developed. Separation was achieved on a Phenomanax Luna C18; 5 μm, 150 mm × 4.6 mm i.d. column using water and methanol 50: 50 (v/v) as mobile phase and detected at 256 nm using PDA detector. Azelnidipine and Telmisartan were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions and stressed samples were analyzed by the proposed method. Linearity, precision, accuracy, specificity and robustness were studied as reported in the International Council for Harmonization guidelines. Linearity of the proposed method was in the range of 4-12 μg mL-1 (r2 = 0.998) for Azelnidipine and 20-60 μg mL-1 (r2 = 0.997) for Telmisartan. Limits of Detection were 1.041 μg mL-1 and 0.208 μg mL-1, while Limits of Quantitation were 3.155 μg mL-1 and 0.631 μg mL-1 for Azelnidipine and Telmisartan respectively. Degradation products produced as a result of stress studies did not interfere with the detection. The proposed stability studies method for simultaneous estimation was found to be specific, accurate and economical that could be applied for routine analysis of drugs in bulk and multi component formulations in quality control laboratories.