Determination of Dapiprazole Hydrochloride in the Presence of Process and Degradation Impurities by a Validated Stability Indicating RP-HPLC Method

Dapiprazole hydrochloride is an alpha-adrenergic blocking agent. Chemically, it is 5,6,7,8-tetrahydro-3-[2-(4-o-tolyl-1-piperazinyl)ethyl]-s-triazolo[4,3-a]pyridine hydrochloride, which is widely used in ophthalmic practice. A stability-indicating RP-HPLC method has been developed and validated which can separate and accurately quantitate dapiprazole related compounds. The method was successfully validated in accordance to ICH guidelines acceptance criteria for system suitability, specificity, linearity, range, precision, accuracy, limits of detection and quantification for the impurities and robustness, following the ICH guidelines. Therefore, the proposed method was suitable for the simultaneous determination of dapiprazole and its process related and degreadation impurities. Finally, the applicability of the method was evaluated in commercial dosage form analysis as well as in stability studies.