International E-publication: Publish Projects, Dissertation, Theses, Books, Souvenir, Conference Proceeding with ISBN. 

Assay Method Development and Validation of Biclotymolby High Performance Liquid Chromatography (HPLC)

Author Affiliations

  • 1Department of Applied Science, Dr. K.N. Modi University, Newai, Rajasthan, India
  • 2Department of Applied Science, Dr. K.N. Modi University, Newai, Rajasthan, India
  • 3Department of chemistry, S.H.S Government P.G College, Dhanapur, Chandauli, India

Res.J.chem.sci., Volume 16, Issue (1), Pages 52-62, February,18 (2026)

Abstract

Biclotymol is a phenolic antiseptic API molecule which generally use for the treatment of mouth and throat infection. It is antibacterial, anti-inflammatory and analgesic. Due to phenolic antiseptic it kills bacteria, Biclotymol have fast acting and long lasting molecule. The Method Validation is applicable for demonstration of method accuracy, method precision, linearity, repeatability, reproducibility, limit of detection(LOD) and limit of quantitation(LOQ) for analysis of Biclotymol for assay. High Performance Liquid Chromatography(HPLC) equipped with VWD detector and stainless steel column 25 cm×4.6 mm, C18 (5µm). From the analytical method validations report, it is concluded that the Assay of Biclotymol is (96.0%- 101.0%).

References

  1. Karpova E, Giacomelli L, Tumietto F (2017)., Role of biclotymol-based products in the treatment of infectious sore throat., European Review for Medical and Pharmacological Sciences, 21(16), 3736–3743.
  2. British Pharmacopoeia (2018)., Stationary Office on behalf of the Medicines and Healthcare Products Regulatory Agency (MHRA)., Monograph for Bisoprolol fumarate.
  3. European Pharmacopoeia (2019)., European Directorate for the Quality of Medicines and Healthcare, Council of Europe, Strasbourg., Мonograph for Biclotymol
  4. ICH Guideline (1998)., Photostability Testing of New Active Substances and Medicinal Products, ICH Topic Q1B, European Medical Agency., CPMP/ICH/279/95, January 1998. ICH Guideline: Stability Testing of New Drug Substance and Product,
  5. ICH Q1A (R2)., European Medical Agency, CPMP/ICH/2736/99, August 2003., ICH Guideline: Validation of analytical procedures: Text and Methodology, ICH Q2(R1), European Medical Agency, CPMP/ICH/381/95, November 2005.
  6. H. Eldridge Faith (1950)., Aldehyde-Phenol Reaction Products and Derivatives., Journal of the American Chemical Society, 72, 837-839, DOI:10.1021/ja01158a049.
  7. Jakub K. Sypien, Thomas A. Zevaco , Annette Flicker, Olaf Walter (2013)., New aluminum 2,2-methylenebis(4-chloro-3-methyl-6-(isopropyl)phenoxides): Structural characterization of an unusual ionic aluminum bisphenoxide [Al(THF)4(Cl)2] +[Al(mcmip)2] −•x THF., Inorganic Chemistry Communications, 30, 69–73. DOI: https://doi.org/10.1016/j.inoche.2013.01.021
  8. Chen, Hsuan-Ying; Liu, Mei-Yu; Sutar, Alekha Kumar; Lin, Chu-Chieh (2009)., Synthesis and structural studies of heterobimetallic alkoxide complexes supported by Bis(phenolate) ligands: Efficient catalysts for Ring-Opening polymerization of L-Lactide., Inorganic Chemistry , 49(2), 665 – 674.
  9. S. Rantsordas, M. Perrin, and A. Thozet. (1978)., Crystal and molecular structures of 2,2-Methylenebis(4-chloro-3-methyl-6-isopropylphenol)., Acta Cryst., B34, 1198-1203. DOI: https://doi.org/10.1107/S0567740878005208.
  10. ICH Topic Q2 (R1) (1996)., Validation of Analytical Procedures; Methodology, Q2 (R1)., International Conference on Harmonization, IFPMA, Geneva 1996.
  11. Lisa (Song) Liu, Ariel Mouallem, Kang Ping Xiao, Jerry Meisel (2021)., Assay of active pharmaceutical ingredients in drug products based on relative response factors: Instrumentation insights and practical considerations., Journal of pharmaceutical and biomedical analysis, 194, 113760.
  12. Lloyd R. Snyder, Joseph J. Kirkland, Joseph L. Glajch. (1997)., Practical HPLC Method Development., Second Publication, A Wilew Interscience Publication, ISBN: 0-471-00703-X.
  13. Manual (2013)., Agilent 1200 Infinity Series Diode Assay Detectors User Manual. Agilent HPLC publication., undefined
  14. Huafu Wang, Gordon J. Provan, Keith Helliwell (2003)., HPLC determination of catechins in tea leaves and tea extracts using relative response factors., Elsevier, Food Chemistry, 307–312, DOI: https://doi.org/10.1016/S0308-8146(02)00510-1.
  15. Sunil K Pandey and R.N. Sharma (2023)., Analytical method development and method validation for the Assay of 5-Chloro-2,3-dihydro-1-one by gas chromatography (GC)., J. Chemtracks, 25(1&2) 225-230.
  16. Naseef Hani and Ramzi Moqadi (2024)., HPLC Method Development and Validation for the Determination of Apixaban and Clopidogrel in Novel Fixed-Dose Combination Tablets., Journal of Chemistry, DOI: http://.doi.org10.1155/2024/26755736.
  17. Nidhal S. Mohammed (2016)., Development and Validation of RP-HPLC Method for the Determination of Hydrochlorothiazide in Bulk Drug and Pharmaceutical Dosage Form., Chromatography Research International, DOI: https://doi.org/10.1155/2016/1693024.
  18. Prafulla Kumar Sahu (2011)., Development and Validation of Stability Indicating RP-HPLC Method for the Determination of Metaxalone in Bulk and its Pharmaceutical Formulations., Journal of Chemistry, DOI: http://.doi.org 10.1155/2011/645710.
  19. FDA (2000)., Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls., Federal Register (Notices), 65(169), 52, 776–777.
  20. The European Medicines Agency, Pre-Authorization Evaluation of Medicines for Human Use. ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology, EMEA/410412/2007: London, 2009., undefined, undefined
  21. Z. Vujic, N. Mulavdi ´ c, M. Smaji ´ c, J. Brbori ´ c, and P. Stankovic, (2012)., Simultaneous analysis of irbesartan and hydrochlorothiazide: an improved HPLC method with the aid of a chemometric protocol., Molecules, 17(3), 3461–3474.
  22. R. Céolin, J. L. Tamarit, M. Barrio, D. Ó. López, B. Nicolaï, N. Veglio, M-A. Perrin and P. Espeau, J. Overall. (2008)., Monotropic Behavior of a Metastable Phase of Biclotymol, 2,2′-Methylenebis(4-Chloro-3-Methyl-Isopropylphenol), Inferred from Experimental and Topological Construction of the Related P-T State Diagram., Journal-of-pharmaceutical-sciences, 97(9), 3927-3941.
  23. Nathalie Mahe, Beatrice Nicolai and Rene Ceolin (2008)., Crystal Structure of Biclotymol-DMSO 1:1 Solvate: 2,2c-Methylenebis- (4-chloro-3-methyl-6-isopropylphenol) dimethylsulfoxide Solvate.., The Japan Society for Analytical Chemistry, Analytical Sciences, 24.
  24. L.J. Farrugia, (1999). J. Appl. Cryst. 32, 837. 7. J. Bernstein and A. T. Hagler, J. Am. Chem. Soc., 1978, 100, 673., undefined, undefined