Validated stability indicating liquid chromatographic determination of ebastine in pharmaceuticals after pre column derivatization: Application to tablets and content uniformity testing

Abstract

An accurate, simple, sensitive and selective reversed phase liquid chromatographic method has been developed for the determination of ebastine in its pharmaceutical preparations. The proposed method depends on the complexation ability of the studied drug with Zn2+ ions. Reversed phase chromatography was conducted using an ODS C18 (150 × 4.6 mm id) stainless steel column at ambient temperature with UV-detection at 260 nm. A mobile phase containing 0.025%w/v Zn2+ in a mixture of (acetonitril/methanol; 1/4) and Britton Robinson buffer (65:35, v/v) adjusted to pH 4.2, has been used for the determination of ebastine at a flow rate of 1 ml/min. The calibration curve was rectilinear over the concentration range of 0.3 - 6.0 μg/ml with a detection limit (LOD) of 0.13 μg/ml, and quantification limit (LOQ) of 0.26 μg/ml. The proposed method was successfully applied for the analysis of ebastine in its dosage forms, the obtained results were favorably compared with those obtained by a comparison method. Furthermore, content uniformity testing of the studied pharmaceutical formulations was also conducted. The composition of the complex as well as its stability constant was also investigated. Moreover, the proposed method was found to be a stability indicating one and was utilized to investigate the kinetics of alkaline and ultraviolet induced degradation of the drug. The first-order rate constant and half life of the degradation products were calculated.

Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium Using New Pencil Graphite Electrode in Their Pure, Synthetic Mixtures, and Combined Dosage Form

“…For that, different fexofenadine solutions their pH values range (2-6) were prepared, the potential was measured for each solution using FEX.Mol graphite sensor, we found that the potential stay stable between pH range (2.5-4.5), at pH value more than 4.5 a noticed decrease in potential was found. For MON.Co sensor, different Montelukast solutions their pH values range (3)(4)(5)(6)(7)(8)(9)(10)(11) were prepared, and the potential was measured for each solution using MON.Co sensor, the effective pH range was found to be (5-9.5), at pH values less than 5, Montelukast drug participated, and more than 9.5 there was a decrease in the measured potential. It was found that there is no requirement for using any buffer, as buffers may involve some obtrusive substances, and because of the wide range of pH for both sensors (I and II).…”

Stability-indicating RP-HPLC method applied to the quantification of anti-histaminic drug ebastine in its oral suspension dosage form

“…Chemical structure of ebastine A thorough study revealed that numerous analytical procedures for estimating ebastine in tablet and syrup dosage forms, either alone or in combination with other medications, have been described, including spectrophotometry (6)(7)(8)(9), HPTLC (10), HPLC (11)(12)(13)(14)(15)(16), and LC-MS/MS (17)(18)(19). There have been very few reports of RP-HPLC techniques (20)(21)(22) for estimating ebastine in tablet and syrup dose forms that are stable. However, no RP-HPLC techniques for estimating ebastine in suspension dose form have been published to date.…”

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].…”