Development of validated stability-indicating chromatographic method for the determination of fexofenadine hydrochloride and its related impurities in pharmaceutical tablets

Abstract

A simple reversed phase high performance liquid chromatographic method with diode array detector (HPLC-DAD) has been developed and subsequently validated for the determination of fexofenadine hydrochloride (FEX) and its related compounds; keto fexofenadine (Impurity A), meta isomer of fexofenadine (Impurity B), methyl ester of fexofenadine (Impurity C) in addition to the methyl ester of ketofexofenadine (Impurity D). The separation was based on the use of a Hypersil BDS C-18 analytical column (250 × 4.6 mm, i.d., 5 μm). The mobile phase consisted of a mixture of phosphate buffer containing 0.1 gm% of 1-octane sulphonic acid sodium salt monohydrate and 1% (v/v) of triethylamine, pH 2.7 and methanol (60:40, v/v). The separation was carried out at ambient temperature with a flow rate of 1.5 ml/min. Quantitation was achieved with UV detection at 215 nm using lisinopril as internal standard, with linear calibration curves at concentration ranges 0.1-50 μg/ml for FEX and its related compounds. The optimized conditions were used to develop a stability-indicating HPLC-DAD method for the quantitative determination of FEX and its related compounds in tablet dosage forms. The drugs were subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compounds and all degradation products. The method was validated according to ICH guidelines in terms of accuracy, precision, robustness, limits of detection and quantitation and other aspects of analytical validation.

Application of SDS Micelles as Carriers for Reliable Determination of Fexofenadine and Its Impurities in Bulk and Pharmaceutical Formulations by Capillary Micellar Electrophoresis

“…[16,17] One of the methods found in the literature that was developed for simultaneous detection of FXN and its related compounds, expanded the analysis to only two structural impurities of FXN by high performance liquid chromatography [18] and a recently reported method was developed for the determination and separation of FXN and its structural impurities using ion-pair chromatography. [19] There are also some reported capillary electrophoretic methods in literature for determination of FXN. One of the methods described determination of FXN in capsules using basic buffer, [20] and the other one was developed for determination of FXN in tablets at low pH conditions.…”

Determination of Some Non-sedating Antihistamines via Their Native Fluorescence and Derivation of Some Quantitative Fluorescence Intensity - Structure Relationships

“…Among these methods are liquid chromatography (HPLC) [6][7][8][9][10][11], gas chromatography (GC) [12], electrochemical [13][14][15][16][17], and spectrophotometric methods (direct UV-, derivative-spectrophotometry, formation of ion-pair complexes, and charge transfer) [18][19][20][21][22].…”

Sensitive Extractional Colorimetric Analysis of Fexofenadine Hydrochloride and Irbesartan Bases Through Acid-Dye Complexation Using Naphthol Blue Black in Pure Form and Pharmaceuticals

“…The drug is official in BP [3] and USP [4], which describe HPLC methods for the assay of fexofenadine hydrochloride. Several analytical methods for the determination of fexofenadine hydrochloride in pharmaceutical formulations have been reported including high performance liquid chromatography [5][6][7][8], spectrophotometry [8][9][10][11][12], conductometry [13], extractive spectrophotometry with bromothymol blue, bromocresol green, bromocresol purple and bromophenol blue [13,14], spectrofluorometry [15], potentiometry [16] and capillary electrophoresis [17,18]. Fexofenadine hydrochloride has been determined in combination with other drugs using high performance liquid chromatography [19][20][21][22][23], high performance thin layer chromatography [24] and spectrophotometry [25][26][27] in combined dosage forms.…”