Salbutamol sulphate is a substantially used anti-asthmatic drug. Aim of this study was to develop a simple and cost-effective spectrophotometric method. The method developed for estimation of Salbutamol sulphate in tablet dosage form is a visible spectrophotometric method using Brady’s reagent. Brady’s reagent is used for qualitative and quantitative analysis of drug compounds containing carbonyl moieities (aldehydes and ketone) as functional group. Brady’s reagent reacts with carbonyl group and it undergoes nucleophilic addition-elimination reaction, a type of condensation reaction, this results in the formation of colored hydrazones. As Salbutamol sulphate contains aromatic carbonyl group (phenol) as functional group, hence Brady’s reagent is used for quantitative estimation of Salbutamol sulphate in tablet dosage form. By this developed assay developed using this reagent, percent label claim results were found to be within limits as per pharmacopoeia limits. The method developed was subjected to validation parameters as per ICH guidelines. The developed method obeyed Beer’s Lambert’s law. Linearity was found to be passed in concentration range of 10 to 50µg/mL. Based on validation results it was concluded that the developed method for the assay of Salbutamol sulphate in tablets was simple, accurate, linear, precise, robust and rugged. Hence the developed method can be applied in routine analysis for the assay of Salbutamol sulphate tablets. This method is simple and superior over other costly and sophisticated analytical procedures.
Cite this article:
Sana Tabassum, M. Ajitha. Quantitative Estimation of Salbutamol sulphate in Tablets using Brady’s reagent by Colorimetric method and Validation of developed method. Res. J. Pharma. Dosage Forms and Tech.2021;13(1):1-6. doi: 10.5958/0975-4377.2021.00001.X
Sana Tabassum, M. Ajitha. Quantitative Estimation of Salbutamol sulphate in Tablets using Brady’s reagent by Colorimetric method and Validation of developed method. Res. J. Pharma. Dosage Forms and Tech.2021;13(1):1-6. doi: 10.5958/0975-4377.2021.00001.X Available on: https://rjpdft.com/AbstractView.aspx?PID=2021-13-1-1
1. Tripathi KD. Respiratory System drugs. Essentials of Medical Pharmacology, Jaypee Brothers Medical Publishers Pvt. Ltd.2013; 7th ed: pp. 221-223.
2. Giovanni Barisione, Michele Baroffio, Emanuele Crimi and Vito Brusasco. Beta-Adrenergic Agonists. Pharmaceuticals. 2010; 3: 1016-1044.
3. Paul Andrzejowski and Will Carroll. Salbutamol in paediatrics: pharmacology, prescribing and Controversies. Pharmacy update British Medical Journal. 2016; 101: 194-197.
4. Hitoshi Kurose. β2 Adrenergic receptors: Structure, regulation and signaling by partial and full agonists: Review Article. Allergology International. 2004; 53:321-330.
5. Rabe KF and Schmidt. Pharmacological treatment of asthma today. European Respiratory Journal.2001; 18(Supp. 34):34s-40s.
6. Naveen MR and Santhosh YL. Asthma: An Overview. Research Journal of Pharmacy and Technology. 2011; 4(6):883-890.
7. Pavithra Dave H and Dr. Preetha. Pathogenesis and Novel Drug for Treatment of Asthma-A Review. Research Journal of Pharmacy and Technology. 2016; 9(9): 1519-1523.
8. Punita Maurya R, Yadunath Joshi N and Vilasrao Kadam J.A Review on Bronchial Asthma. Research Journal of Pharmacology and Pharmacodynamics.2013; 5(4):257-265.
9. European Pharmacopoeia 6.0. Govt. of Europe. Pharmacopeia Europea. European Pharmacopoeia Commission. Monograph of Salbutamol sulphate from EP 6.0(0687e). 2008; pp. 2857-2859.
10. Sachin Kadam S, Tambe ST, Grampurohit ND, Gaikwad DD. Review Article On: Chemical Importance of Brady’s reagent. International Journal of Research in Pharmacy and Chemistry. 2012; 2(4):1086-1092.
11. Morgan Kandrac. Factors affecting the 2, 4-dinitrophenyl hydrazine reaction with lipid carbonyls. Thesis.New Jersey.2018. Available from: URL: https://rucore.libraries.rutgers.edu/rutgers-lib/59128/PDF/1/play/.
12. Girish Pai K, Vamshi Krishna T, Lalit Kumar, Sreenivasa Reddy M, Shreya Singh and Vibha V. Evaluation of few Marketed products of Salbutamol sulphate syrup IP. Asian Journal of Research in Pharmaceutical Sciences. 2013; 3(3):114-116.
13. Salve P S. Development of sustained release beads for salbutamol sulphate using ion exchange resin. Asian Journal of Pharmacy and Technology. 2011; 1(4):104-118.
14. Vaseeha Banu TS, Sukhen Som, Mohamed Khaleel and Nirmal Havannavar T. Transdermal Drug Delivery System of Salbutamol Sulphate: Formulation and Evaluation. Research Journal of Pharmaceutical Dosage Forms and Technology. 2009; 2(1):56-61.
15. Tasnuva Haque1, Kanij Fatema, Md Zakiur Rahman, Muhammad Shahidul Islam and Sayma Ara Dayna. Assessment and In Vitro Release Profiles of Salbutamol Sulphate from Hypromellose and Carbomer Based Matrix Tablets. Research Journal of Pharmacy and Technology. 2010; 3(2):442-448.
16. Anubha Khaleand Amrita Bajaj. Liposomal Nebulising Solutions of Salbutamol Sulphate-A Characterisation Study. Research Journal of Pharmacy and Technology. 2011; 4(9):1373-1378.
17. Somnath M. Kedar, Pallavi Chaudhari M and Rachana Patil N. Formulation and Evaluation of Sustain Release Tablet of Salbutamol Sulphate by Wet Granulation Method Using Release Retarding Agent. Research Journal of Pharmacy and Technology. 2012; 5(2):277-280.
18. Arifa Begum Sk, Padma Sree V, Anusha 2, Keerthi Veronica Z, Vinitha Sree P, Prameela K, Nazeema MD, Padmalatha K. Formulation and Evaluation of Pediatric Oral Soft Jellies of Salbutamol Sulphate. Research Journal of Pharmacy and Technology. 2018; 11(11):4939-4945.
19. Mohauman Mohammad AL-Rufaie, Aymen Abdul Rasool Jawad and Hawraa Mohammed Sadiq. Colorimetric Estimation for Salbutamol-sulphate in Pure Form and in Different Types of Pharmaceutical. Journal of Pharmacy and Pharmaceutical Research. 2017; 1(1):1-7.
20. Selvadurai Muralidharan and Jayaraj Kumar. High Performance Liquid Chromatographic Method Development and Its Validation for Salbutamol. British Journal of Pharmaceutical Research.2012; 2(4): 228-237.
21. Yogesh S, Dau Dayal A, Santosh B, Sandeep P, Amit M, Pramod Kumar S and Ragini J. Method Development and Validation of Salbutamol sulphate and its Related Impurities by Rp-Hplc.International Journal of Pharmaceutical Sciences.2011; 3(1): 1178-1197.
22. Ankit Tyagi, Nitin Sharma, Karan Mittal, Rajashree Mashru, Tilakraj Bhardwaj, Jai Malik and Arti Thakkar. HPTLC-Densitometric and RP-HPLC Method Development and Validation for Determination of Salbutamol Sulphate, Bromhexine Hydrochloride and Etofylline in Tablet Dosage Forms. Pharmaceutica Analytica Acta. 2015; 6(3): 1-9.
23. Indian Pharmacopoeia. Govt. of India Vol-III. Ghaziabad: Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission. Salbutamol sulphate Monograph. 2010; pp. 2088-2089.
24. ICH Q2 (R1) Guidelines. Validation of Analytical Procedures: Text and Methodology. Current Step 4 Version.pp:1-17. Available from: URL: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf