Determination of budesonide R(+) and S(−) isomers in pharmaceuticals by thin-layer chromatography with UV densitometric detection

Abstract

Key WordsThin-layer chromatography Densitometric detection Budesonide R (+) and S (-) isomers of budesonide R (+) and S ( ) isomers in pharmaceuticals.For the TLC separation Allufolien cellulose-coated plates were used as stationary phase and a solution of J3-cyclodextrin with methanol as mobile phase. SummaryA new HPTLC separation and determination of budesonide R (+) and S (-) isomers by densitometry at 245 nm has been developed. A cellulose-coated TLC plate and a 1% aqueous solution of 13-cyclodextrin with methanol as mobile phase were used for the separation. Under the conditions established high sensitivity was achieved, with detection limits 34.64-43.72 ng, as well as a high recovery 98.76 -103.60% for the individual isomers. Validation of the method confirmed the high precision and accu racy of the results.

Development and Validation of Stability-Indicating High-Performance Thin-Layer Chromatographic Method for Budesonide

“…The stress study proposed in this method is based on guidance by Bakh et al [3]. A detailed literature search indicates that there are a few RP-HPLC methods [4][5][6][7][8][9][10][11][12], a few high-performance thin-layer chromatographic (HPTLC) methods [13][14][15] and a few LC-MS methods [16] developed for this drug. However, degradation products in stability studies of budesonide were not reported in any of these papers.…”

Recent Advances in the Analysis of Steroid Hormones and Related Drugs

“…86 A tandem TLC-HPLC method is described for screening cosmetic products for the presence of undeclared synthetic corticosteroids. 87 Chiral selectors improved the separation of diastereomeric steroid pairs, e.g., the addition of β-cyclodextrin to the mobile phase in the case of the separation of R(+)-and R(-)-budenoside on cellulose-coated HPTLC plates, 88 and impregnation of the silica gel TLC plate with dcamphorsulfonic acid/copper(II) acetate for the separation of the diastereomeric 21-ester derivatives of prednisolone formed with racemic tetrahydrophthalic acid. 89 Some papers deal with the possibilities of applying only seldom-used stationary phases e.g., Florisil, derivatized reversed-phase systems for steroid separations and with the elucidation of the separation mechanism.…”

Pitfalls and success of experimental design in the development of a mixed MEKC method for the analysis of budesonide and its impurities

“…Several methods have been described for the analysis of BD in combined dosage form [2,3], serum or plasma [4][5][6][7][8][9][10] and in bronchoalveolar lavage [11]. Analysis of BD epimers has been performed both in dosage form [12,13] and in plasma [14][15][16]. An HPLC method can be found in European Pharmacopoeia [17] for the assay of BD and its related substances and it has recently been applied for the estimation of BD tablets impurities [18].…”