A Simple and Improved HPLC-PDA Method for Simultaneous Estimation of Fexofenadine and Pseudoephedrine in Extended Release Tablets by Response Surface Methodology

Abstract

A simple RP-HPLC method has been developed for simultaneous estimation of fexofenadine and pseudoephedrine in their extended release tablet. The method was developed based on statistical design of experiments (DoE) and Response Surface Methodology. Separation was achieved on double end-capped C18 column (250 mm × 4 mm, 5 μm). In this experiment, two components of mobile phase, namely, acetonitrile (% v/v) and methanol (% v/v), were the factors whereas retention and resolution of the chromatographic peaks were the responses. The effects of different composition of factors on the corresponding responses were investigated. The optimum chromatographic condition for the current case was found as an isocratic mobile phase consisting of 20 mM phosphate buffer (pH 6.8) and acetonitrile and methanol in a ratio of 50 : 36 : 14 (% v/v) at a flow rate of 1 mL/min for 7 minutes. The retention of pseudoephedrine and fexofenadine was found to be 2.6 min and 4.7 min, respectively. The method was validated according to the ICH and FDA guidelines and various validation parameters were determined. Also, forced degradation studies in acid, base, oxidation, and reduction media and in thermal condition were performed to establish specificity and stability-indicating property of this method. Practical applicability of this method was checked in extended release tablets available in Bangladeshi market.

Comparative Study of Chemical Stability of Two H1Antihistaminic Drugs, Terfenadine and ItsIn VivoMetabolite Fexofenadine, Using LC-UV Methods

“…In addition, there are still attempts to obtain new derivatives of TER and FEX with higher activities and lower side effects [3]. What is more, some reports indicating chemical instability of FEX has been published [15, 16, 19, 21–24]. Bearing in mind that all active pharmaceutical substances, and in consequence respective medicinal products, should maintain the appropriate potency and purity throughout their availability on the market, the need to obtain new active pharmaceutical substances with higher chemical stability is obvious.…”

“…They were mainly elaborated for different pharmacokinetic measurements [11–14]. However, more HPLC methods were elaborated for determination of FEX in pharmaceuticals, as an individual drug [15–18] or in the presence of other agents like pseudoephedrine [19] or parabens [20]. Some of the methods from the literature were described as stability-indicating procedures capable of determining FEX in the presence of its degradation products [20–24].…”

“…On the contrary, some data presenting insufficient stability of FEX occurred in the literature [15, 16, 19, 21–24]. Its chemical stability was previously examined in a solid state at 80°C for 1–8 h [21, 22] as well as in solutions, i.e., in 0.1–1 M HCl, 0.1–1 M NaOH, and 3–30% H 2 O 2 [16, 17, 19, 21–23]. As far as photodegradation of FEX is concerned, the exposure of FEX to the day light and irradiation at 254 nm was carried out [16, 21–24].…”

Separation and Assay of Four Antihistamine Drugs Diphenhydramine, Chlorpheniramine, Cyproheptadine and Fexofenadine in Pharmaceutical Forms by a Single HPLC Method

“…There were also many chromatographic methods for assaying fexofenadine in formulations, which have been reported in the bibliography [13][14][15][16][17].…”

Spectral analysis of overlapped absorption bands of binary mixtures—an application on combination of pseudoephedrine sulphate and loratadine mixture

“…Various spectrophotometric methods were established for the determination of pseudoephedrine [2][3][4]. Several chromatographic methods were applied for the determination of PSE containing HPLC [5][6][7][8][9][10], HPTLC [11][12][13], GC [14,15], and CE [16,17], and also, many electrochemical methods were reported [18][19][20].…”