Satya Narayan Tripathy, Suryakanta Swain, Bikash Ranjan Jena* and Abhisek Sahu

Department of Pharmaceutical Analysis, School of Pharmacy and Life Science, Centurion University of Technology and Management, Jatani, Bhubaneswar, Odisha, India

*Corresponding Author: Bikash Ranjan Jena, Department of Pharmaceutical Analysis, School of Pharmacy and Life Science, Centurion University of Technology and Management, Jatani, Bhubaneswar, Odisha, India.

Received: November 25, 2022; Published: January 04, 2023

Abstract

The current investigation signifies, a simple, affordable, precise, and accurate UV spectrophotometric method to estimate and validate lumefantrine concentrations in bulk and pharmaceutical formulations. Shimadzu twin beam UV-VIS spectrophotometer operated by UV probe software was used in the study. The resulting absorbance at a maximum wavelength of 268 nm was observed using the solvent 0.1N HCL. Numerous validation metrics, including accuracy, precision, linearity, and optical characteristics, were used to optimise the established method. Within a concentration range of 10-60 µg/mL, the regression co-efficient (R²) value of 0.997 was incorporated to obtain the linearity Graph. Less than 2%, of the results for accuracy and precision studies were executed, which shows increasing accuracy and precision levels. Due to low %RSD values in the recovery exploration, no excipients were included in the formulation of the tablet dosage form. The proposed method's accuracy study was confirmed at (80%, 100%, 120%) three levels, and the outcomes were validated in accordance with ICHQ2R1 guidelines. These findings indicate that the procedure has practical value as a tool for quality control when analysing drugs in their tablet dosage forms in the pharmaceutical industry.

Keywords: Bisoprolol; Validation; Precision; Accuracy; Optical Characteristics

References

1. Alina Diana Panainte and Nela Bibire. “A New Method for the Assay of Bisoprolol Using Bromocresol Green”. Revista de Chimie -Bucharest (Bucharest) (2014): 916-920.
2. https://pubchem.ncbi.nlm.nih.gov/compound/Bisoprolol-fumarate
3. Rajesh S Jadhav and Jagdish V Bharad. “Analytical Method Development and Validation of Spectroscopic Method for Estimation of Metoprolol Succinate”. Scholars Research Library-Der Pharmacia Lettre (2017): 285-297.
4. Mallela Vijaya Jyothi., et al. “A New Method development and Validation of Dual Wavelength UV Spectrophotometric Method for Simultaneous Estimation of Bisoprolol Fumarate and Amlodipine Besylate in Combined Dosage Form”. Asian Journal of Biochemical and Pharmaceutical Research (2015): 28-36.
5. Tuljarani G., et al. “Quantitative Determination of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Forms By Spectrophotometry”. International Journal of Chemical Sciences (2010): 2253-2258.
6. Jena BR., et al. “Validated UV Spectrophotometric Methods for the Estimation of Letrozole in Solid Dosage Forms”. International Journal of Pharmaceutical Sciences and Nanotechnology (2018): 11.
7. Jena BR., et al. “UPLC Analytical Method Development and Validation for the Simultaneous Estimation of Paracetamol and Caffeine Capsules Dosages Form”. Pharmaceutical Regulatory Affairs: Open Access 6 (2017): 186.
8. Priyanka S., et al. “Development and Validation of UV Spectrophotometric Methods for Simultaneous Estimation of Amlodipine Besylate and Bisoprolol Fumarate in Pure and Tablet Dosage Form”. International Journal of Universal Pharmacy and Bio Sciences, May-June, (2015): 107-117.
9. Jena BR., et al. “UV spectrophotometric method development and quantitative estimation of glipizide in bulk and pharmaceutical dosage forms”. International Journal of Drug Research and Technology (2017): 112-122.
10. International conference on Harmonization Guidance for Industry. In. Q2A Text on Validation of Analytical Methods, Switzerland: IFPMA (1994): 1-4.
11. Sahoo CK., et al. “Validation of Analytical Methods: A Review”. Journal of Chromatography and Separation Techniques (2018): 112.
12. Jena BR., et al. “Response Surface Methodology Driven Systematic Development of a Stability- indicating RP-UPLC Method for the Quantification of Aliskiren: A Renin Inhibitor”. Journal of Pharmaceutical Research International 52B (2021): 195-211.
13. Armbruster DA and Pry T. “Limit of blank, limit of detection and limit of quantitation”. Clinical Biochemist Reviews 29 (2008): S49-52.
14. Jena BR., et al. “AQbD Driven Development of an RP-HPLC Method for the Quantitation of Abiraterone Acetate for its Pharmaceutical Formulations in the Presence of Degradants”. Turkish Journal of Pharmaceutical Sciences6 (2021): 718-729.
15. In: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: text and methodology Q2 (R1), ICH Steering Committee, Geneva, Switzerland (2005).
16. Panchumarthy R., et al. “A Review on Step-by-Step Analytical Method Validation”. IOSR Journal of Pharmacy 5 (2015): 07-19.
17. Amgad M., et al. “Design, Synthesis, and Biological Evaluation of Novel 5-Substituted-2- (3,4,5-trihydroxyphenyl)-1,3,4-oxadiazoles as Potent Antioxidant”. American Journal of Organic Chemistry2 (2016): 54-80.
18. Amgad M., et al. “Design, Synthesis, and Biological Evaluation of New 5-Substituted-1,3,4-thiadiazole-2-thiols as Potent Antioxidants”. Researcher7 (2018): 21-43.

Citation

Citation: Bikash Ranjan Jena., et al. “New Validated UV Spectrophotometric Method for the Quantification of Bisoprolol Fumarate in its Pharmaceutical Dosage Form". Acta Scientific Pharmaceutical Sciences 7.2 (2023): 04-09.

Copyright

Copyright: © 2022 Bikash Ranjan Jena., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.