Stability-Indicating High-Performance Thin-Layer Chromatography Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate in Bulk Drug and Pharmaceutical Dosage Form

Abstract

Objective: The objective of the present work was to develop validated stability-indicating high-performance thin-layer chromatographic method for simultaneous estimation of formoterol fumarate dihydrate (FFD) and fluticasone propionate (FP) in bulk drug and pharmaceutical dosage form.
 Methods: Pre-coated silica gel aluminum plates 60 F-254 were used as stationary phase. The mixture of toluene:ethyl acetate:formic acid (98%) (6:4:0.1; v/v/v) was used as a mobile phase. The densitometric quantification was carried out at 233 nm. The method was validated according to the ICH guidelines. The specificity and stability indicating the capability of the method were proven though degradation studies. Both drugs were subjected to acid (0.1N HCl) and base (0.1N NaOH) hydrolysis, oxidation (3% v/v H2O2), photolytic, and neutral degradation conditions.
 Results: The selected mobile phase resolved peaks of FFD and FP with Rf values 0.27±0.10 and 0.64±0.10, respectively. Determination coefficients of calibration curves were found to be 0.998 and 0.999 in the range of 1–3.5 μg/spot and 10–60 μg/spot for FFD and FP with an accuracy of 99.09% for FFD and 99.20% for FP. The degradation products of FFD and FP were resolved from the pure drug with significant differences in their retention factor values.
 Conclusion: The developed method is simple, accurate and can be successfully applied for quantification of FFD and FP in bulk drug and pharmaceutical dosage form, contributing to improve the quality control and assure the therapeutic efficacy.

Method Development and Validation of the Chromatographic Analysis of Fluticasone Propionate and Salmeterol Xinafoate Combination in Solutions and Human Plasma Using HPLC With Uv Detection

“…The same method was used to prepare methanolic QC solutions for each medication of the four separated solutions. The obtain the following final concentrations (20,40,60, and 80 μg/ml) of both FP and SX.…”

“…Several chromatographic techniques have been published in the literature for analysis purposes of fluticasone propionate (FP) and/or, salmeterol xinafoate (SX) in their pharmaceutical preparations and different matrices. For example these methods include UVspectrometric methods [6,7], HPLC with UV detection methods [8][9][10][11][12][13], HPLC-MS/MS methods [14,15], UPLC-MS/MS methods [16,17], UPLC-PDA method [18], and HPTLC method [19,20].…”

Budesonide Compatibility Study With Excipients for Preparation of Nanoparticle

“…Restricted solution phase stability analysis is necessary even for a substance intended to be formulated into dosage forms to ensure that the drug does not degrade in gastrointestinal fluids. This knowledge will allow us to choose the right excipients and solvents to use in budesonide nanoparticles [6][7][8].…”

A Molecularly Imprinted Polymeric Sensor Based on Poly(methyldopa) for Electrochemical Quantification of Formoterol in Raw Material and Pharmaceutical Dosage Form

“…It can be purchased as a single-entity or in various formulations combined with inhaled corticosteroids [15][16]. Literature survey revealed several UV spectrophotometry methods for determination of FFD with other drugs combination [17][18][19][20], several chromatographic methods including: UPLC [21], HPTLC [22][23][24] and HPLC [25][26][27][28][29][30][31] for simultaneous quantitation of FFD with other drugs combination, and voltammetric method based on square wave and differential pulse of formoterol in aqueous solution using 0.5 M sulphuric acid over the linear range 8×10 -6 -6×10 -5 M [32].…”