VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE DETERMINATION OF BISOPROL FUMARATE WITH BROMOCRESOL PURPLE IN TABLETS

Abstract

Introduction. Our previous studies optimized the conditions of sample preparation and developed a method for the quantitative determination of bisoprolol fumarate with bromocresol purple in a solid dosage form – “Bisoprol” tablets. Since validation is experimental proof that the proposed method for quantitative determination of bisoprolol is suitable for the set goals and objectives. Therefore, it is necessary to investigate the main validation parameters, the results of which will indicate not only the correctness of the presented methodology, but also its compliance with the requirements of the National Pharmacopoeia, as well as its use in practical Pharmacy. The Aim of the Study. The aim of the research – validation of the method for quantitative determination of bisoprolol fumarate by reaction with bromocresol purple in tablets. Research Мethods. The experiment was conducted using a device – a spectrophotometer “Shimadzu UV1800” (UVProbe 2.62), quartz cuvettes 1 cm in size, “Bisoprol” tablets with a dosage of 10 mg, a pharmacopoeial standard sample (PSS) of bisoprolol fumarate (“SigmaAldrich”, ≥98 %, high-performance liquid chromatography), acetonitrile R (Sphera Seven p.a.), bromocresol purple (BCP) “Sigma – Aldrich” (≥98 %, HPLC), methods of mathematical statistics. Results and Discussion. The study of validation characteristics was carried out in accordance with the requirements of the State Pharmacopoeia of Ukraine (SFU) 2nd edition. The main validation parameters studied were: linearity, accuracy, precision, convergence and robustness. As a result of the tests conducted, the developed method turned out to be linear, since the detection limit was 0,9024, the quantification limit was 2,7344, which corresponds to the specified acceptance criteria. The value of Δz was equal to 0,21, which is less than the critical value (1,6 %), and therefore the developed method is convergent. The systematic error is 0,03 %, which is also less than critical and indicates the correctness of this quantification method. Conclusions. As a result of studying the main validation parameters, it was found that the developed method for determining the quantitative content of bisoprolol fumarate from BCP is linear, convergent, correct, and precise and can be used at chemical and pharmaceutical enterprises by laboratories for quality control of medicinal products to conduct pharmaceutical analysis of the substance bisoprolol and medicines based on it.