Development and methodology for the estimation of bisaprolol in pharmaceuticals
DOI:
https://doi.org/10.11603/mcch.2410-681X.2017.v0.i2.7798Keywords:
Bisoprolol, identification, thin layer chromatography, validation.Abstract
Introduction. The number of drugs introduced into the pharmaceutical market is increasing every year. These drugs may be either new entities or partial structural modification of the existing one. The objective of any analytical measurement is to obtain consistent, reliable and accurate data. Thin layer chromatography, or TLC, is a method for analyzing mixtures by separating the compounds in the mixture. TLC can be used to help determine the number of components in a mixture, the identity of compounds, and the purity of a compound.
Aim: Analysis of bisoprolol is described in Pharmacopeia but aim of our researches was to improve to more simple, selective, more accurate, precise, reliable, less expensive methods by TLC of bisoprolol in pharmaceuticals and for using this methods for analysis of their metabolites in next step of researches.
Materials and Methods: The present study is assessed system solvents of bisoprolol for thin layer chromatography.
Results and Discussion: Method of identification of bisoprolol in medicines by TLC has been developed. Established that the most optimal Rf observed using mobile phases: ammonia (25%)-propanol (30: 70). The detection limits of bisoprolol in this system is 0.4 mcg. We explored the validation characteristics - specificity and suitability of the chromatographic system that met, the eligibility criteria established by the SPU.
Conclusion: We have been developed chromatographic method of identification of bisoprolol in pharmaceuticals. The proposed method is economical, simple and applicable to the analysis of pharmaceutical dosage forms.
References
www.medicines.org.uk
Review on analytical method development and validation. Research and reviews / R. Patil, T. Deshmukh, V. Patil, K. Khandelwal // Journal of Pharmaceutical Analysis. – 2014. – № 3 (3). – P. 1–10.
ICH Topic Q2 (R1) Validation of analytical procedures: text and methodology.
Liliya L. Development of methods for identification of calcium channel blockers in medicines / L. Liliya, K. Dmutro, S. Stanislav // International Journal of Research Ayurveda Pharmaceutical. – 2016. – № 7 (2). – P. 88–91.
Logoyda L. Development and validation of new methods of analysis for the determination of different natural and synthetic original active pharmaceutical ingredients in medicines / L. Logoyda // Duphat. – 2015. – P. 48.
Logoyda L. Validation of chromatographic methods of analysis for the determination of active pharmaceutical ingredients in different medicines / L. Logoyda // Pharma School association for pharmaceutical development and scientific research. Egypt. – 2016. – P. 34.
