Development and Validation of a High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Two Binary Mixtures Containing Ketorolac Tromethamine with Phenylephrine Hydrochloride and with Febuxostat

Abstract

A validated and highly selective high-performance thin-layer chromatography (HPTLC) method was developed for the determination of ketorolac tromethamine (KTC) with phenylephrine hydrochloride (PHE) (Mixture 1) and with febuxostat (FBX) (Mixture 2) in bulk drug and in combined dosage forms. The proposed method was based on HPTLC separation of the drugs followed by densitometric measurements of their spots at 273 and 320 nm for Mixtures 1 and 2, respectively. The separation was carried out on Merck HPTLC aluminum sheets of silica gel 60 F254 using chloroform-methanol-ammonia (7:3:0.1, v/v) and (7.5:2.5:0.1, v/v) as mobile phase for KTC/PHE and KTC/FBX mixtures, respectively. Linear regression lines were obtained over the concentration ranges 0.20-0.60 and 0.60-1.95 µg band(-1)for KTC and PHE (Mixture 1), respectively, and 0.10-1.00 and 0.25-2.50 µg band(-1) for KTC and FBX (Mixture 2), respectively, with correlation coefficients higher than 0.999. The method was successfully applied to the analysis of the two drugs in their synthetic mixtures and in their dosage forms. The mean percentage recoveries were in the range of 98-102%, and the RSD did not exceed 2%. The method was validated according to ICH guidelines and showed good performances in terms of linearity, sensitivity, precision, accuracy and stability.

Application of a nanostructured sensor based on graphene‐ and ethyl 2‐(4‐ferrocenyl[1,2,3]triazol‐1‐yl)acetate‐modified carbon paste electrode for determination of methyldopa in the presence of phenylephrine and guaifenesin

“…Phenylephrine decreases the congestion and the production of mucus thereby reducing discomfort and making breathing easier . To date, just a few methods have been introduced in the literature for the determination of phenylephrine, most of which are spectrophotometric or chromatographic methods and electroanalytical techniques have been rarely reported …”

A novel quality by design approach for development and validation of a green reversed‐phase HPLC method with fluorescence detection for the simultaneous determination of lesinurad, febuxostat, and diflunisal: Application to human plasma

“…Concerning FEB, a number of HPLC methods had been reported using photo diode array [8,17], fluorescence [18,19], and mass detection [20][21][22]. It was also investigated by high-performance TLC [23,24], GC [25], MEKC [26], and spectrofluorimetric methods [15,27]. Different methods were also reported for DIF analysis including HPLC [28][29][30], CE [31], high-performance TLC [32], GC [33], and spectrofluorimetric methods [9,30].…”

Two different synchronous spectrofluorimetric approaches for simultaneous determination of febuxostat and ibuprofen

“…From the literature survey, the analysis of FEB was performed using different methods including spectrofluorimetry [10][11][12][13], spectrophotometry [14,15], HPLC [9,[16][17][18][19], LC-MS [20][21][22], micellar electrokinetic capillary chromatography [23], HPTLC [24][25][26][27] and GC [28]. Similarly, the assay of IBU has been achieved applying different methods including spectrofluorimetry [29][30][31][32], spectrophotometry [33,34], HPLC [35][36][37], LC-MS [38,39], HPTLC [37], capillary zone electrophoresis [40,41], potentiometry [42] and GC [43,44].…”