Abstract:

The aim of the work. Method validation of verapamil hydrochloride in pharmaceutical forms by spectrophotometric quantitative determination according to the State Pharmacopoeia of Ukraine. Materials and Methods. Verapamil hydrochloride working standard, bromocresol green and the sample of finished dosage forms were used. Reagents and solvents: A standard sample of verapamil hydrochloride, bromocresol green, acetone. Analytical equipments: Spectrophotometer Specord 200, electronic scales AVT-120-5DM, ultrasonic bath ELMASONICE60 H. Results and Discussion.  It was experimentally established that verapamil hydrochloride reacts with bromocresol green in acetone medium to form the colored reaction product with absorption maximum at 409 nm. The proposed method was subject to validation tests. The linearity, precision, accuracy, robustness and scope of application were tested to validate the method. Particularly, linearity of the method is confirmed throughout the range of concentrations 60–135 % (1.9648–4.4208 mg/100 ml). The proposed method meets the requirements to the State Pharmacopoeia of Ukraine for methods of quantitative determination of medicinal substances. Thus, this method could be widely applicable for the quality control and routine analysis. Conclusions. The validation of the spectrophotometric method of quantitative determination of verapamil hydrochloride in pharmaceutical formulation according to the standardization validation procedure is carried out. It is proved that the method developed by such validation characteristics as linearity, precision, correctness and robustness is correct.

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