DEVELOPED REVERSE PHASE CHROMATOGRAPHIC METHOD FOR ANALYSIS OF PARACETAMOL AND HOMATROPINE METHYL BROMIDE IN RIABASAM TABLET
DOI:
https://doi.org/10.61841/w8a3fb61Keywords:
Paracetamol, , Homatropine methyl bromide, s: , Method analysis, RP- HPLC.Abstract
A developed chromatographic method has been proved in this work to identification Paracetamol and Homatropine methyl bromide in raw material and riabasam tablets. Chromatographic separation system was accomplished using C18 column (250 mm ×4.6 mm) with particle size 5µm. Isocratic elution of mobile phase prepared by dissolve 1.742 g of 1- pentansulfonic acid sodium salt in 750 ml of water, add 220 ml of acetonitrile then the whole solution was adjusted to a pH 3 with 2 M hydrochloric acid, complete to 1000 ml with water. The mobile phase was pumped at a flow rate of 1 ml/min with UV detector at 225nm at ambient temperature at (25±2 C̊) and injection volume as 100 μL. The method was linear over the concentration range of paracetamol and homatropine methyl bromide were 4–30 μg/mL 10-110 μg/mL respectively. The retention time of Paracetamol and Homatropine methyl bromide were found to be 5.4 minutes and 9.7 minutes respectively. Limit of detection and limit of quantification of paracetamol and Homatropine methyl bromide concentrations were found to be (0.442μg/mL and 0.0885 μg/mL) (1.473 μg/mL, 0.295 μg/mL) respectively. The average percentage recoveries of paracetamol were within 100.20 to 102.79% and homatropine methyl bromide were within 98.82 to 100.15%. The suggested procedure has been ratified according to ICH guidelines, validation of method showed it to be particular, durable, accurate and can be adoptable for quality control analysis of paracetamol and homatropine methyl bromide in riabasam tablets.
Downloads
References
1. SC. Sweetman, Martindale the Complete Drug Reference. 34th ed. London: The Pharmaceutical Press, 2005.
2. Control of pain in adults with cancer. SIGN Guide- lines.106 Section 6.1 and 7.1.1, 2008.
3. T. P. Devi, A. Setti, S. Srikanth, S. Nallapeta, S.C. Pawar and J.V. Rao, “Method development and validation of paracetamol drug by RP-HPLC”, Journal of Medical and Allied Sciences, vol. 3, no. 1, pp. 8-14, Feb. 2013.
4. Sh. Narwade, “Qualitative and Quantitative Analysis of Paracetamol in Different Drug Samples by HPLC Technique”, Journal of Applied Chemistry, vol. 7, no. 8, pp. 46-49, Aug. 2014.
5. M. Attimarad, “Simultaneous determination of paracetamol and lornoxicam by RP-HPLC in bulk and tablet formulation”, Pharmaceutical methods, vol. 2, no. 1, pp. 61-66, Jan-Mar. 2011.
6. A.K. Hewavitharana, S. Lee, P.A. Dawson, D. Markovich and P.N. Shaw, “Development of an HPLCMS/MS method for the selective determination of paracetamol metabolites in mouse urine”, Analytical biochemistry, vol. 374, no. 1, pp. 106-111, Mar. 2008.
7. S. Azhagvuel and R. Sekar, “Method development and validation for the simultaneous determination of cetirizine dihydrochloride, paracetamol, and phenylpropanolamine hydrochloride in tablets by capillary zone electrophoresis”, Journal of pharmaceutical and biomedical analysis, vol. 43, no. 3, pp. 873-878, Feb. 2007.
8. A. Safavi, N. Maleki and O. Moradlou, “A selective and sensitive method for simultaneous determination of traces of paracetamol and p‐aminophenol in pharmaceuticals using carbon ionic liquid electrode”, Electroanalysis: An International Journal Devoted to Fundamental and Practical Aspects of Electroanalysis, vol. 20, no. 19, pp. 2158-2162, Sep. 2008.
9. R. Burakham, S.Duangthong, L.Patimapornlert, N.Lenghor ,S. Kasiwad and L.Srivichai, “ Flow-injection and sequential-injection determinations of paracetamol in pharmaceutical preparations using nitrosation reaction", Analytical sciences, vol. 20, no. 5, pp. 837-840, May. 2004.
10. M. Knochen, J.Giglio and B.F.Reis, “ Flow injection spectrophotometric determination of paracetamol in tablets and oral solutions”, Journal of pharmaceutical and biomedical analysis, vol. 33, no. 2, pp. 191-197, Sep. 2003.
11. M.D.L.A. Oliva, R.A.Olsina and A.N.Mas, “Selective spectrofluorimetric method for paracetamol determination through coumarinic compound formation”, Talanta , vol. 66, no. 1, pp. 229-235, Mar.2005.
12. A.F. Lavorante, C.K.Pires and B.F.Reis , “ Multicommuted flow system employing pinch solenoid valves and micro-pumps: Spectrophotometric determination of paracetamol in pharmaceutical formulations”, Journal of pharmaceutical and biomedical analysis, vol. 42, no. 4 pp. 423-429, Oct. 2006.
13. S.K. Sharma, G.B.Barot and P.J.Multani, “Development and validation of vierdot’s and q-ratio method for the estimation of paracetamol, domperidone and flunarizine in solid oral dosage form”, International Journal of Pharmacy and Pharmaceutical Sciences, vol. 5, no. 2, pp. 347-351, Jan. 2013.
14. A.B. Moreira, H.P.Oliveira, T.D.Atvars, I.L.Dias,G.O. Neto and E.A. Zagatto, “Direct determination of paracetamol in powdered pharmaceutical samples by fluorescence spectroscopy", Analytica Chimica Acta, vol. 539, no.1-2, p. 257-261, May. 2005.
15. Pubchem, home page https://pubchem.ncbi.nlm.nih.gov, (accessed on March 1st, 2017).
16. S. Larissa and D. Leite, “Flow-injection turbidimetric determination of Homatropine Methylbromide in pharmaceutical formulations using silicotungstic acid as precipitant reagent”, Talanta, vol. 69, no. 1, pp. 239- 242, Mar. 2006.
17. M.R. Ganjali, Z. Memari, S. Riahi, F. Faridbod, P. Norouzi, M.A. Sian and M. A. J. Braz, “A New Homatropine Potentiometric Membrane Sensor as a Useful Device for Homatropine Hydrobromide Analysis in Pharmaceutical Formulation and Urine: A Computational, study”, Journal of the Brazilian Chemical Society, vol. 20, no.5, pp. 926-934, Apr. 2009.
18. J. Sreeramulu, M. Aswartha and K. Siddareddy, “Concurrent analysis of homatropine methylbromide and hydrocodone bitartrate related impurities in reverse phase chromatography by Uplc”, Journal of Pharmaceutical and Biological Sciences, vol.5, no. 4, pp. 161-167, 2017.
19. M. Li, B. Zhang,J. Yu, J.Wang and X. Guo, “ Enantiomeric separation and simulation study of eight anticholinergic drugs on an immobilized polysaccharide-based chiral stationary phase by HPLC”, New Journal of Chemistry, vol. 42, no. 14, pp. 11724-11731, Jun. 2018.
Downloads
Published
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
