DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF GUAIFENESIN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL IN TABLET DOSAGE FORM
Keywords:Guaifenesin, Dextromethorphan HBR, Diphenhydramine HCL, Double divisor ratio spectra derivative spectrophotometry
Â Objective: This study aimed to develop spectrophotometry method by double divisor ratio spectra derivative to determine the levels of guaifenesin (GUA), dextromethorphan hydrobromide (DMP), and diphenhydramine hydrochloride (DPH) in tablet dosage form using ethanol as solvent.
Methods: The method is based on the use of the coincident spectra of the derivative of the ratio spectra obtained using a double divisor (sum of two spectra) and measuring at either the maximum or minimum wavelengths. Then, the method was applied to determine the levels of GUA, DMP, and DPH in tablet dosage form.
Results: The application of double divisor ratio spectra derivative spectrophotometry method for the determination of GUA, DMP, and DPH was performed on the first derivative at Î”Î» 2 (Î» 280.0 nm, Î» 286.1 nm, and 260.2 nm, respectively). The selection of wavelengths based on wavelengths gives the best result. The mean % recoveries were found to be in 100.60%, 99.95%, and 101.74% for GUA, DMP, and DPH, respectively.
Conclusion: The method is successfully applied to analyze GUA, DMP, and DPH in pharmaceutical formulation with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range.
Rao BK, Kumari JI, Nageswara RM, Babu CR. A new and sensitive UV spectrophotometric method for the determination of guaifenesin in dosage forms. Int J Pharm Pharm Res 2015;3:139-48.
Drozd J. Comparison of classic and derivative UV spectrophotometric methods for determination of dextromethorphani hydrobromidum. Acta Fac Pharm Univ Comenianae 2012;59:22-9.
Ul Hassan SA. Method development of diphenhydramine HCl (C17H21NO. HCl) on spectrophotometer. IOSR J Appl Chem 2015;8:59-62.
Pushpalatha E, Tejaswini P, Najboonbi M, Vineesha S, Madhanna MD, Kumar TA, et al. Development of UV spectroscopic method for the determination of guaifenesin in bulk and formulation. Int J Pharm Res Anal 2015;5:90-5.
Bhattacharyya I, Bhattacharyya SP, Kyal C, Choudhury P, Dhakal B, Ghosh SK. Estimation and validation of stability indicating UV spectrophotometric method for the determination of guaifenesin in presence of its degradant products. Int J Pharm Pharm Sci 2013;5 Suppl 1:262-8.
Prabhu PP, Das P, Krishna NM, Subrahmanyam EV. Spectrophotometric method for development of guaiphenesin in pharmaceutical dosage form. Int J Pharm Chem Biol Sci 2013;3:881-6.
Raghava RT, Kumar NA, Kumar SR, Reddy AM, Rao NS, Rao IV. Development and validation of a stability-indicating RP-HPLC method for the simultaneous estimation of guaifenesin and dextromethorphan impurities in pharmaceutical formulations. Corp Chromatogr 2013. Article ID: 315145, 12 pages.
Senthilraja M, Giriraj P. Reverse phase HPLC method for the simultaneous estimation of terbutanile sulphate, bromhexine HCl and guaifenesin in cough syrup. Asian J Pharm Clin Res 2011;4:13-5.
Ansari M, Kazemipour M, Shahriar M. Simultaneous quantitation of theophylline and guaifenesin in syrup by HPLC, derivative and derivative ratio spectrophotometry for quality control purposes. Iran J Pharmacol Thera 2006;5:67-72.
Ahmed NR, Lottfi SN. High performance liquid chromatographic method for the determination of guaifenesin in pharmaceutical syrups and in environmental samples. Baghdad Sci J 2012;10:1014-21.
Ã‡aÄŸlar H, BÃ¼yÃ¼ktuncel E. HPLC method development and validation simultaneous determination of active ingredients in cough and cold pharmaceuticals. Int J Pharm Pharm Sci 2014;6:421-8.
Elmosallamy MA, Amin AS. New potentiometric and spectrophotometric methods for the determination dextromethorphan in pharmaceutical preparations. Anal Sci 2014;30:419-25.
Krunali T, Vijya P, Rohit M, Meshram DB. UV spectrophotometric method for estimation of dextromethorphan in bulk and syrup formulation by area under curve method. Int J Pharm Chem Sci 2013;2:1961-4.
Vijayalakshmi R, Bhargavi S, Dhanaraju MD. Simultaneous UV spectrophotometric determination of cetrizine and dextromethorphan in tablet dosage form. E J Chem 2010;7:314-8.
Al Bratty M, Hashem H, Noureldeen A, Manoharan G, Towhari F. Conductometric determination of the antihistaminic diphenhydramine hydrochloride using silver nitrate as a titrant. Int J Pharm Pharm Sci 2015;7:72-6.
Ali NW, Abdelkawy M, Abdelhamid NS. Simultaneous determination of paracetamol and diphenhydramine HCl mixture in the presence of their degradation products. IOSR J Pharm Biol Sci 2013;6:44-52.
Gohel RV, Parmar SJ, Patel BA. Development and validation of double divisor-ratio spectra derivative spectrophotometric method for simultaneous estimation of olmesartan medoxomil, amlodipine besylate and hydrochlorthiazide in tablet dosage Form. Int J Pharm Tech Res 2014;6:1518-25.
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