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Development of stability indicating method for separation and characterization of benidipine forced degradation products using LC-MS/MS.

The present study describes forced degradation of benidipine as per ICH prescribed guidelines Q1A (R2) and Q1B. Benidipine was degraded under hydrolysis (neutral, acidic, and alkaline), hydrogen peroxide-induced oxidation, and UV light-mediated photolytic degradations. A total of fourteen degradation products were found in all degradation studies, which includes in four hydrolytic degradation products, eight oxidative degradation products and four degradation products in photolytic degradation products. A selective stability-indicating method using XBridge BEH C18 (250 × 4.6 mm, 5 μm) with gradient elution program using ammonium acetate (10 mM, 4.8 pH, acetic acid) and acetonitrile, was developed. The flow rate was maintained at 1 mL min-1 . All degradation products were well separated on developed HPLC method and characterized by using LC-MS/MS data. As the method shows great utility in identifying and separating of benidipine and its degradation products with sufficient resolution, it can be used in different laboratories for the quality control of drug in daily routine analysis and stability studies.