Simultaneous estimation of six anti‐diabetic drugs—glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human plasma assay

Abstract

This paper describes a convenient method for the separation and simultaneous determination of six anti-diabetic drugs viz., glibenclamide (GLB), gliclazide (GLC), glipizide (GLZ), pioglitazone (PGL), repaglinide (RPG) and rosiglitazone (RGL) in pharmaceutical formulations. Also, the assay has been shown applied to support quantification of the six anti-diabetic drugs in human plasma. The analytes were either injected directly onto the column after suitable dilution (pharmaceutical formulation analysis) or a simple extraction procedure, using acetonitrile, from human plasma spiked with anti-diabetic drugs and internal standard (IS). Ternary gradient elution at a flow rate of 1 mL/min was employed on an Intertisl ODS 3V column (4.6 x 250 mm, 5 microm) at ambient temperature. The mobile phase consisted of 0.01 m formic acid (pH 3.0), acetonitrile, Milli Q water and methanol. Celecoxib was used as an IS. The six anti-diabetic drugs were monitored at a wavelength of 260 nm. The nominal retention times of RGL, PGL, GLZ, GLC, GLB, IS and RGL were 11.4, 13.3, 14.8, 17.6, 20.78, 22.1 and 25.4 min, respectively. The assay developed for formulation analysis was found to be accurate and precise. The calibration curves ranged from 0.1 to 100 microg/mL for all analytes with the exception of GLB, where the range was 0.3-100 microg/mL. The plasma assay was validated for parameters such as specificity, accuracy and extraction recovery. The proposed method is simple, selective and can be extended for routine analysis of anti-diabetics in pharmaceutical preparations and in biological matrices.

Validated stability-indicating RP-HPLC UV method for simultaneous determination of metformin and repaglinide

“…Several HPLC methods have been reported in the literature for quantitative determination of MET alone [4] or in combination with other drugs in tablets [5][6][7], human serum and other biological fluids [8][9]. Similarly, a few HPLC methods have been reported for the quantitative determination of REPA in tablets alone or in combination with other drugs [10][11][12], and in human serum and other biological fluids [13,14]. Only one UV spectroscopic method has been reported for the simultaneous determination of these compounds, which, however, lacks stabilityindicating nature [15].…”

Encapsulation and release characteristics of glibenclamide loaded calcium-alginate beads

“…Solutions were pre-treated and maintained at 37 ± 0.5 ºC and the paddles were set at 75 rpm. At appropriate time intervals (10,20,30,45 and 60 min), 5 mL samples were collected, filtered through 0.45 μ filter paper and analyzed for drug content by HPLC at 230 nm. An equal volume of fresh medium was added to the test solution to maintain constant volumes.…”

“…13 Different research has reported that glibenclamide has a low bioavailability, which is attributed to its poor dissolution properties. [14][15][16] Different methods have been reported to determine glibenclamide levels in various biological fluids, such as plasma 17,18 and serum, 19 in pharmaceutical formulation analyses [20][21][22] or in simultaneous determination of anti-diabetic drugs. 23 Our objectives were to formulate calcium-alginate beads containing glibenclamide by ionotropic gelation, characterize the resulting microparticles, evaluate the release characteristics of glibenclamide loaded calcium-alginate beads in an in vitro dissolution test, and compare it with two commercially available trademarks (Daonil ® and Glibetab ® ).…”

Dissolution test for glibenclamide tablets

“…Several assay techniques have been described for quantitative determination of glibenclamide in biological fluids; these include procedures based on high performance liquid chromatography (HPLC) [10][11][12][13][14][15][16][17][18] , fluorometry 19 , radioimmunoassay [20][21][22] and gas chromatography 23 . A few reports deal with the analysis of the drug in these dosage forms; such procedures include: micellar electrokinetic capillary chromatography 24 , RP-HPLC 15,25 , fluorometry 26 , TLC-UV spectrophotometry 27 , derivative spectrophotometry 28 , UV spectrophotometry 29 and colorimetry 30 .…”

“…A few reports deal with the analysis of the drug in these dosage forms; such procedures include: micellar electrokinetic capillary chromatography 24 , RP-HPLC 15,25 , fluorometry 26 , TLC-UV spectrophotometry 27 , derivative spectrophotometry 28 , UV spectrophotometry 29 and colorimetry 30 . At the present time there is no dissolution test for glibenclamide tablets reported in any pharmacopeia.…”