Author(s):
Rani Potawale, Shankar Wadje, Mrunal Bulbule, Vaishali Shirsat
Email(s):
ranipotawale@azamcampus.org
DOI:
10.52711/0974-360X.2022.00500 
Address:
Rani Potawale1*, Shankar Wadje1, Mrunal Bulbule2, Vaishali Shirsat2
1Department of Pharmaceutical Chemistry, Allana College of Pharmacy, Savitribai Phule Pune University, 2390/B, K. B. Hidayatulla Road, Azam Campus, Camp, Pune 411001, India.
2Department of Pharmaceutical Analysis, Bombay College of Pharmacy, Kalina, Mumbai - 400098, India.
*Corresponding Author
Published In:
Volume - 15,
Issue - 7,
Year - 2022
ABSTRACT:
A simple, step by step, cost-effective, accurate, sensitive, and selective validated High Performance Thin Layer Chromatographic method for simultaneous determination of Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin in syrup formulation has been developed and validated. HPTLC separation was achieved on Merck aluminum HPTLC plates precoated with silica gel 60 F254. The solvent system comprised of Chloroform: Methanol: Ethyl acetate: Acetic acid: Formic acid (7.0:1.4: 0.8:1.0:0.5 v/v). Densitometric detection wavelength at 200 nm was used in reflectance-absorbance mode. The retention factors were found to be 0.32±0.02, 0.55± 0.02, and 0.72±0.02, for Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin respectively. Results were found to be linear over a range of 200 - 700ng band-1, 1000 - 7000ng band-1, and 400-1200ng band-1 for Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin, respectively. The percent assay was found to be 98.47%, 98.47%, and 99.23%, for Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin, respectively in marketed formulation. The developed densitometric method was validated by following the International Council on Harmonisation (ICH) guideline. The developed and validated chromatographic method can be applied for routine quality control of Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin in the combined syrup dosage form used in study.
Cite this article:
Rani Potawale, Shankar Wadje, Mrunal Bulbule, Vaishali Shirsat. Simultaneous Estimation of Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin in Combined Dosage Form by HPTLC Method. Research Journal of Pharmacy and Technology. 2022; 15(7):2997-1. doi: 10.52711/0974-360X.2022.00500
Cite(Electronic):
Rani Potawale, Shankar Wadje, Mrunal Bulbule, Vaishali Shirsat. Simultaneous Estimation of Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin in Combined Dosage Form by HPTLC Method. Research Journal of Pharmacy and Technology. 2022; 15(7):2997-1. doi: 10.52711/0974-360X.2022.00500 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-7-22
REFERENCES:
1. The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, Suran Budavari, Editor emeritus, Merk Research Laboratories, 13th ed: pp. 8181, 9080.
2. British pharmacopeia, British pharmacopeia commission, London. 2008; pp.1079-80.
3. Indian pharmacopeia, Indian pharmacopeia commission, Ghaziabad. 2008; pp. 1790-91.
4. Patel JJ. Chorawala H. Dedania ZR. Vijendraswamy SM. Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Doxofylline and Terbutaline Sulphate in Combined Dosage Form. Asian Journal of Pharmaceutical Analysis. 2015; 5(2): 74-8. doi: 10.5958/2231-5675.2015.00012.5
5. Karthick RK. Kavitha J. Lakshmi KS. Quantification of Terbutaline Sulphate in Pharmaceutical Formulation by UV Spectrophotometric aided Multivariate Calibration Technique. Research Journal of Pharmacy and Technology. 2020; 13(2): 767-73. doi: 10.5958/0974-360X.2020.00145.6
6. Sangshetti JN. Takate G. Ahmed RZ. Zaheer Z. Method Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Terbutaline Sulphate and Guaiphenesin in Bulk and Tablet Dosage Form. Journal of Chemical and Pharmaceutical Research. 2017; 9(1): 100-7.
7. Faiyazuddin M et al. A validated HPTLC method for determination of terbutaline sulfate in biological samples: Application to a pharmacokinetic study. Saudi Pharmaceutical Journal. 2011; 19(3): 185-91. doi.org/10.1016/j.jsps.2011.03.004
8. Itagimatha N. Manjunatha DH. RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms. Annales pharmaceutiques françaises. 2019; 77(4): 295-301. DOI: 10.1016/j.pharma.2019.02.004
9. Indian Pharmacopoeia, Government of India Ministry of Health and Family Welfare; Vol 3, Controller of Publications, Delhi. 2007; pp. 83.
10. Potdar VH. Kuchekar BS. Patil SS. Selective Visible Spectrophotometric Estimation of Ambroxol Hydrochloride in Presence of Cetirizine Hydrochloride in Tablets. Asian Journal of Research Chemistry. 2009; 2(3): 278-79. Available from: https://ajrconline.org/AbstractView.aspx?PID=2009-2-3-14
11. Seervi C. Pawar K. Dhabale PN. Gonjari ID. Raut C. Gharge D. Development and Validation of UV Spectrophotometric Method of Ambroxol Hydrochloride in Bulk and Pharmaceutical Formulation. Asian Journal of Research in Chemistry. 2009; 2(4): 547-49. Available from: https://online.org/AbstractView.aspx?Journal=Asian%20Journal%20of%20Research%20in%20Chemistry&PID=2009-2-4-47
12. Chitlange S. Pandkar S. Tawar M. Wankhede S. Simultaneous Spectrophotometric Estimation of Salbutamol Sulphate and Ambroxol Hydrochloride by Using Various Solvent in Bulk as well as in Tablet Formulation. Asian Journal of Research in Chemistry. 2011; 4(5): 746-49.
13. Pendharkar NA. Chaple DR. Simultaneous Estimation of Azithromycin and Ambroxol Hydrochloride in Combined Tablet Dosage Form by Multicomponent Mode of Analysis. Asian Journal of Research in Chemistry. 2010; 3(2): 296-98.
14. Sekar V. Bajivali SK. Vanitha C. Jayaseelan S. Perumal P. RP-HPLC Method Development and Validation for Simultaneous Estimation of Ambroxol and Levocetirizine in Solid Dosage Form. Asian Journal of Research in Chemistry. 2011; 4(7): 1097-99.
15. Nagappan KV et al. A RP-HPLC Method for Simultaneous Estimation of Ambroxol Hydrochloride and Loratidine in Pharmaceutical Formulation. Research Journal of Pharmacy and Technology 1(4): 2008; 366-69.
16. Sagathiya K. Bagada H. Development and validation of RP-HPLC and HPTLC method of analysis for simultaneous estimation of ambroxol HCL, Dextromethorphan HBR, and Guaifenesin in pharmaceutical cough cold preparation and statistical comparison of developed methods. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6: 312-16.
17. Singh VD. Daharwal SJ. Analytical Methods for Quantitative Estimation of Ambroxol HCl in Pharmaceutical Preparation: A Review. Research Journal of Pharmacy and Technology. 2014; 7(10): 1208-19.
18. Indian pharmacopoeia, Ghaziabad, Indian Pharmacopoeia. 2007; pp. 558-59.
19. Patel NC. Patel DB. Pruthviraj K. Chaudhari. Spectrophotometric estimation of Ambroxol Hydrochloride, Guaifenesin and Levosalbutamol Sulphatein syrup. Asian J. Research Chem. 6(4): April 2013; Page 407-14.
20. Chahal MK. Yadav PK. Bumbrah GS. Sharma RM. Thin-layer chromatographic analysis of some common over the counter (OTC) cough–cold preparations. Egyptian Journal of Forensic Sciences. 2016; 6(4): 351-60.
21. Bhavani P. Seelam M. Rao KP. Stability indicating RP-HPLC method for the estimation of diethylcarbamazine citrate, guaiphenesin and chlorpheniramine maleate. International Journal of Applied Pharmaceutics. 2018; 10(1): 124-35. doi:10.22159/ijap.2018v10i1.22180
22. Abdelwahab NS. Abdelaleeme EA. Stability indicating RP-HPLC method for simultaneous determination of guaifenesin and pseudoephedrine hydrochloride in the presence of syrup excipients. Arabian Journal of Chemistry. 2017; 10(2): 2896-901. doi.org/10.1016/j.arabjc.2013.11.019
23. International Conference on Harmonization, ICH harmonized tripartite guideline validation of analytical procedures: text and methodology, Q2 (R1) ICH. Geneva, 2005.