СПЕКТРОФОТОМЕТРИЧНЕ ВИЗНАЧЕННЯ КАРВЕДІЛОЛУ В ТАБЛЕТКАХ

Анотація

SPECTROPHOTOMETRIC DETERMINATION OF CARVEDILOL IN TABLETS

Y. Zhuk, S. Vasjuk, I. Verоvkina

Zaporozhye State Medical University, Zaporozhye

Summary: in this investigation a visible spectrophotometric method for the determination of carvedilol based on the absorbance of colored product of the reaction between carvedilol and bromcresol purple in acetone medium at 399 nm measurement was developed. The optimal conditions for the quantitative determination of carvedilol in the content of pharmaceutical drugs were established. The validation of the worked out procedure on such validated characteristics as linearity, precision, accuracy and robustness was carried out.

Keywords: spectrophotometric analysis, carvedilol, bromcresol purple.

Introduction. Carvedilol (1-(9H-carbazol-4-yloxy)-3-[2-(2-methoxyphenoxy)ethylamino]propan-2-2) belongs to a group of medicines called beta-adrenergic blocking agents, that are indicated for the treatment of hypertension angina pectoris and heart failure.

Our aim is to develop a simple, accurate and valid method for the spectrophotometric determination of carvedilol.

Purposes:

• establish optimal conditions of the photometric reaction between carvedilol and bromcresol purple;
• develop the method for the determination of carvedilol in pharmaceutical formulations;
• carry out validation of the worked out procedure.

Methods of analysis.

Object of research: tablets «Corvazan» 25 mg (Arterium), tablets «Coriol» 12,5 mg (KRKA), tablets «Coriol» 25 mg (KRKA).

Reagents and Chemicals: standard solution of carvedilol, bromcresol purple, acetone. All reagents and chemicals used were of analytical grade.

Instrument: spectrophotometer Specord 200, electronic balance ABT-120-5PM, ultrasonic bath ELMASONIC 60Н.

Results and discussion.

Linearity. The analytical parameters such as molar absorptivity, Beer’s law limits and Sandell’s sensitivity values were calculated.

Precision. The developed methods give the result with repeatability sufficient for dependable determination the investigated substance in pharmaceutical formulations.

Accuracy. Accuracy established by analyte addition technique.

Robustness. Determined factors that influence on the absorbance value: reagent quantity and timing stability.

Sample solutions stable during 30 min.

Addition to sample solution ±10 % bromcresol purple solution is not change the absorbance value.

Conclusions. Established that reaction between carvedilol and bromcresol purple proceeds in acetone medium at room temperature.

Molar absorption coefficient is 2,13·10⁴.

Developed the method of spectrophotometric determination of carvedilol in pharmaceutical formulations.

Proved that the method is valid on such validated characteristics as linearity, precision, accuracy and robustness.