APPLICATION OF TWO ADVANCED DERIVATIVE SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULPHATE, AMBROXOL HYDROCHLORIDE AND THEOPHYLLINE IN PURE AND COMMERCIAL FORMULATIONS
DOI:
https://doi.org/10.22159/ijcpr.2022v14i3.1976Keywords:
Ambroxol hydrochloride, Derivative Spectrophotometric method, Derivative ratio spectra zero-crossing spectrophotometry, Double divisor ratio spectra derivative spectrophotometry, Salbutamol sulphate, TheophyllineAbstract
Objective: Two advanced spectrophotometric methods have been proposed for the simultaneous determination of Salbutamol sulphate, Ambroxol hydrochloride and Theophylline in pure and pharmaceutical formulations. The proposed methods exclude the hectic steps of time-consuming sample preparations or purification or separation steps. There is no any spectrophotometric method has been avail for simultaneous estimation of the ternary mixture containing Salbutamol sulphate, Ambroxol hydrochloride and Theophylline.
Methods: The methods are derivative ratio spectra zero-crossing method and double divisor ratio spectra derivative method respectively. Both the methods are found to be rapid, accurate, precise, reliable and economical as well. The developed methods show best results in terms of linearity, accuracy, precision, limit of detection and limit of quantification for standard laboratory mixtures of pure drugs and marketed formulations.
Results: The range for Salbutamol sulphate, Ambroxol hydrochloride and Theophyllineare found to be 1-35 µg ml-1, 5-35 µg ml-1and 6-60 µg ml-1 respectively. For the derivative ratio spectra zero-crossing method, the values of the limit of detection are found to be 0.3161 µg ml-1, 0.2212 µg ml-1 and 0.2910 µg ml-1 and the values limit of quantification are found to be 0.9571 µg ml-1, 0.7412 µg ml-1 and 0.9671 µg ml-1 for Salbutamol sulphate, Ambroxol hydrochloride and Theophylline respectively. For double divisor ratio spectra derivative method, limit of detection values is found to be 0.3251 µg ml-1, 0.2591 µg ml-1 and 0.2640 µg ml-1 and the limit of quantification values are found to be 0.9870 µg ml-1, 0.8650 µg ml-1 and 0.8812 µg ml-1 for Salbutamol sulphate, Ambroxol hydrochloride and Theophylline respectively.
Conclusion: The common excipients and additives did not interfere in the determinations of any of the drugs while being analysed for commercial formulations. These two spectrophotometric methods, which determine SS, AH, and THE simultaneously, are simple, specific, accurate, precise, rapidly, and economically, indicating that they can be used routinely in pharmaceutical analysis. As a result, derivative spectrophotometry may be used effectively for the simultaneous determination of SS, AH and THE in the combined dosage forms without any prior separation of individual drugs.
Downloads
References
British Pharmacopoeia. SW8 5NQ, London. 2009;2:1808-9.
British Pharmacopoeia. SW8 5NQ, London. 2009;1:117-8.
British Pharmacopoeia. SW8 5NQ, London. 2009;2:2007-8.
Pandya HN, Berawala HH, Khatri DM, Mehta PJ. Spectrofluorimetric estimation of salbutamol sulphate in different dosage forms by the formation of inclusion complex with β-cyclodextrin. Pharm Methods. 2010;1(1):49-53. doi: 10.4103/2229-4708.72231, PMID 23781416.
AL-Rufaie MM, Jawed AR, Hawraa MS. Colorimetric estimation for salbutamol-sulfate in pure form and in different types of pharmaceuticals. J Pharm Pharm Res. 2016;1(1):1-7.
Narayana A, Rao CN, Sivakumar K. Spectrophotometric determination of ambroxol hydrochloride and its formulations based on charge transfer complex reaction. Int J Pharm Sci Res. 2015;6(4):738-42.
Babu AR, Thippeswamy B, Vinod AB, Ramakishore EG, Anand S, Senthil D. Determination of theophylline in rabbit plasma by triple quadrupole LC/MS. Pharm Methods. 2011;2(4):211-7. doi: 10.4103/2229-4708.93388, PMID 23781459.
Srinivasan KK, Shirwaikar A, Joseph A, Jacob A, Prabu LS. Simultaneous estimation for the analysis of salbutamol sulphate and ambroxol hydrochloride in solid dosage forms by ultraviolet spectrophotometry. Indian Drugs. 2005;42(9):576-9.
Kowsar S, Banu S, Kumar R, Duganath N, Bharath P, Devanna N. A new rp-hplc method development and validation for simultaneous estimation of salbutamol sulphate and theophylline in the pharmaceutical syrup dosage form. Int J Pharm Res Scholars. 2013;2(3):218-26.
El-Sayed AA, El-Salem NA. Recent developments of derivative spectrophotometry and their analytical applications. Anal Sci. 2005;21(6):595-614. doi: 10.2116/analsci.21.595, PMID 15984192.
Dave HN, Mashru RC, Thakkar AR. Simultaneous determination of salbutamol sulphate, bromhexine hydrochloride and etofylline in pharmaceutical formulations with the use of four rapid derivative spectrophotometric methods. Anal Chim Acta. 2007;597(1):113-20. doi: 10.1016/j.aca.2007.06.035, PMID 17658320.
Fitria A, Muchlisyam B, Siti MS. Development and validation of double divisor ratio spectra derivative spectrophotometry method for ternary mixture of guaifenesin, dextromethorphan HBR, and diphenhydramine HCl in the tablet dosage form. Asian J Pharm Clin Res. 2018;11:1-3.
Afkhami A, Bahram M. Mean centering of ratio spectra as a new spectrophotometric method for the analysis of binary and ternary mixtures. Talanta. 2005;66(3):712-20. doi: 10.1016/j.talanta.2004.12.004, PMID 18970043.
Lotfy HM, Tawakkol SM, Fahmy NM, Shehata MA. Successive spectrophotometric resolution as a novel technique for the analysis of ternary mixtures of pharmaceuticals. Spectrochim Acta A Mol Biomol Spectrosc. 2014;121:313-23. doi: 10.1016/j.saa.2013.10.090, PMID 24263128.
Tarinc D, Golcu A. Development and validation of spectrophotometric methods for determination of some cephalosporin group antibiotic drugs. J Anal Chem. 2012;67(2):144-50. doi: 10.1134/S1061934812020128.
Rote AR, Bari PD. Ratio spectra derivative and zero-crossing difference spectrophotometric determination of olmesartan medoxomil and hydrochlorothiazide in the combined pharmaceutical dosage form. AAPS PharmSciTech. 2009;10(4):1200-5. doi: 10.1208/s12249-009-9318-y. PMID 19862625.
Darwish HW, Bakheit AH, Naguib IA. Comparative study of novel ratio spectra and isoabsorption point-based spectrophotometric methods: application on a binary mixture of ascorbic acid and rutin. J Anal Methods Chem. 2016;2:1-12.
Sawsan AAR, Manal MF, Manal KD, Hala EZ, Zeinab A. Spectrophotometric methods for simultaneous determination of gatifloxacin and dexamethasone in their binary mixture. Indo Am J Pharm Res. 2015;5:3048-57.
Lotfy HM, Tawakkol SM, Fahmy NM, Shehata MA. Validated stability-indicating spectrophotometric methods for the determination of lidocaine hydrochloride, calcium dobesilate, and dexamethasone acetate in their dosage forms. Anal Chem Lett. 2013;3:201-25.
Hamed MELF, Mokhtar MM, Hammad SF, Elsheikh SH. Different ratio spectra methods for simultaneous determination of olmesartan medoxomil, hydrochlorothiazide and amlodipine besylate. J Innov Pharm Biol Sci. 2016;3:166-81.
Rote AR, Bari PD. Ratio spectra derivative and zero-crossing difference spectrophotometric determination of olmesartan medoxomil and hydrochlorothiazide in the combined pharmaceutical dosage form. AAPS PharmSciTech. 2009;10(4):1200-5. doi: 10.1208/s12249-009-9318-y, PMID 19862625.
Dave HN, Mashru RC, Thakkar AR. Simultaneous determination of salbutamol sulphate, bromhexine hydrochloride and etofylline in pharmaceutical formulations with the use of four rapid derivative spectrophotometric methods. Anal Chim Acta. 2007;597(1):113-20. doi: 10.1016/j.aca.2007.06.035, PMID 17658320.
Hajian R, Soltaninezhad A. The spectrophotometric multicomponent analysis of a ternary mixture of paracetamol, aspirin, and caffeine by the double divisor-ratio spectra derivative method. J Spectrosc. 2013;2013:1-7. doi: 10.1155/2013/405210.
Youssef RM, Maher HM. A new hybrid double divisor ratio spectra method for the analysis of ternary mixtures. Spectrochim Acta A Mol Biomol Spectrosc. 2008;70(5):1152-66. doi: 10.1016/j.saa.2007.10.049, PMID 18093870.
Published
How to Cite
Issue
Section
Copyright (c) 2022 H. N. DAVE, R. C. MASHRU
This work is licensed under a Creative Commons Attribution 4.0 International License.