STUDY OF VALIDATION CHARACTERISTICS OF THE UV SPECTROPHOTOMETRIC TECHNIQUE FOR THE SIMULTANEOUS DETERMINATION OF PERINDOPRIL ARGININE AND BISOPROLOL FUMARATE IN TABLETS

Abstract

SUMMАRY. Hypertension is the most common disease of the cardiovascular system. Analyzing recommendations for its treatment, angiotensin-converting enzyme (ACE) inhibitors are often prescribed, among which a fixed combination of perindopril arginine and bisoprolol fumarate is suggested. The currently existing analytical methods for determining this combination of active pharmaceutical ingredients (APIs) are quite labor-intensive, non-selective and require the use of expensive equipment and appropriate reagents, so it was decided to develop a new method for quantifying the studied APIs, which will be express, accurate, selective and will comply with the principles of "green" chemistry.

The aim – to validate the UV spectrophotometric technique for the simultaneous determination of perindopril arginine and bisoprolol fumarate tablets.

Material and Methods. Spectrophotometer "Shimadzu UV1800" using the UVProbe 2.62 software package, quartz cuvettes (1 cm), tablets "Prestylol" 5 mg/10 mg, pharmacopoeia standard samples (PSS): perindopril arginine, bisoprolol fumarate ("SigmaAldrich", ≥98%, high-performance liquid chromatography), methanol P ("Honeywell Riedelde Haen™", 99.9 %)), methods of mathematical statistics.

Results. Validation was carried out according to the requirements of the State Pharmacopoeia of Ukraine (SFU) according to the main validation characteristics: linearity, correctness, convergence, precision and robustness. The technique turned out to be linear (MB for perindopril arginine 0.98 μg/ml, MCV – 2.96 μg/ml; MB for bisoprolol fumarate – 0.82, MCV – 2.49), which meets the acceptance criteria. The value of the relative confidence interval of the value ∆z is 0.23 for perindopril arginine and 0.05 for bisoprolol fumarate, which is less than the critical value (1.6 %), and therefore the technique is convergent. The systematic error for perindopril arginine is 0.05%, for bisoprolol fumarate – 0.06 %, which is less than critical and indicates the correctness of the developed technique.

Conclusions. As a result of the validation of the proposed method of quantification, the main validation characteristics have been studied and it has been established that the proposed method for quantifying the investigational substances of medicinal substances is linear, convergent, correct, precise, stable and can be used by laboratories for quality control of medicinal products for the analysis of investigational substances of medicinal substances and drugs based on them.