Derivative Spectrophotometry Applied to the Determination of Triprolidine Hydrochloride and Pseudoephedrine Hydrochloride in Tablets and Dissolution Testing
A spectrophotometric method was developed for simultaneous quantification of pseudoephedrine hydrochloride (PSE) triprolidine hydrochloride (TRI) using second derivative method (zero-crossing technique). The second derivative amplitudes of PSE and TRI were measured at 271 and 321 nm, respectively. The calibration curves were linear in the range of 200 to 1,000 g/ml for PSE and 10 to 50 g/ml for TRI. The method was validated for specificity, accuracy, precision, limit of detection and limit of quantitation. The proposed method was applied to the assaying and dissolution of PSE and TRI in commercial tablets without any chemical separation. The results were compared with those obtained by the official USP31 method and statistical tests showed that there is no significant between the methods at 95% confidence level. The proposed method is simple, rapid and suitable for the routine quality control application. KeywordsTriprolidine, Pseudoephedrine, Derivative spectrophotometry, Dissolution testing.
 T. C. Westfall and D. P. Westfall, Adrenergic agonists and antagonists. Goodman and Gilman's the pharmacological basis of therapeutics, editor, L. L. Brunton, J. S. Lazo and K. L. Parker, 11th ed, McGraw-Hill, New York, 2006, p. 260.
 J. E. Hoover, Histamine and antihistamine drugs. Ramignton The Science and Practice of Pharmacy, vol. 21, 2005, pp. 1546-1550.
 L. Diamond, K. Gerson, A. Cato, K. Peace and J. G. Perkins, An evaluation of triprolidine and pseudoephedrine in the treatment of allergic rhinitis. Ann Allergy., vol. 47(2), Aug 1981, pp. 87-91.
 USP31, the 31st United States Pharmacopoeia 2008, the U.S. Pharmacopoeial Convension, Inc., Rockville, MD, 2008, pp. 3125-3127.
 J. G. Ramaekers and J. F. O'Hanlon, High-performance liquid chromatographic assay for the determination of paracetamol, pseudoephedrine hydrochloride and triprolidine hydrochloride. J Pharm Biomed Anal., vol.12(3), Mar 1994, pp. 379-382.
 A. Meran, J. Morse and T. G. Gibbs, High performance liquid chromatographic assay for the determination of paracetamol pseudoephedrine HCl triprolidine HCl in pharmaceutical preparations. Pak J Pharm Sci., vol. 6(1), Jan 1993, pp. 29-34.
 G. Davidson and L. M. M. Mkoji, The simultaneous assay of triprolidine, pseudoephedrine and dextromethorphan in combined preparations by derivative-difference spectrophotometry. J Pharm Biomed Anal., vol. 6(5), 1988, pp. 449-460.
 M. Palabiyik, E. Din and F. Onur,Simultaneous spectrophotometric determination of pseudoephedrine hydrochloride and ibuprofen in a pharmaceutical preparation using ratio spectra derivative spectrophotometry and multivariate calibration techniques. J Pharm Biomed Anal., vol. 34(3), Feb 2004, pp. 473-483.
 H. Mahgoub, A. A. Gazy, F. A. El-Yazbi, M. A. El-Sayed and R. M. Youssef, Spectrophotometric determination of binary mixtures of pseudoephedrine with some histamine H1-receptor antagonists using derivative ratio spectrum method. J Pharm Biomed Anal., vol. 31(4), Mar 2003, pp. 801-809.
 ICH-Q2(R1) Validation on Analytical Procedures: Text and Methodology, 2005.