Stability-indicating HPLC method for simultaneous determination of terbutaline sulphate, bromhexine hydrochloride and guaifenesin

Abstract

The aim of the present study was the development and subsequent validation of a simple, precise and stability-indicating reversed phase HPLC method for the simultaneous determination of guaifenesin, terbutaline sulphate and bromhexine hydrochloride in the presence of their potential impurities in a single run. The photolytic as well as hydrolytic impurities were detected as 3,5-dihydroxybenzoic acid, 3,5-dihydroxybenzaldehyde, 1-(3,5-dihydroxyphenyl)-2-[(1,1-dimethylethyl) amino]-ethanone from terbutaline, 2-methoxyphenol and an unknown impurity identified as (2RS)-3-(2-hydroxyphenoxy)-propane-1,2-diol from guaifenesin. The chromatographic separation of all the three active components and their impurities was achieved on Wakosil II column, using phosphate buffer (pH 3.0) and acetonitrile as mobile phase which was delivered initially in the ratio of 80:20 (v/v) for 18 min, then changed to 60:40 (v/v) for next 12 min, and finally equilibrated back to 80:20 (v/v) for 10 min. Other HPLC parameters were: Flow rate at 1.0 ml/min, detection wavelengths 248 and 280 nm, injection volume 10 μl. The calibration graphs plotted with five concentrations of each component were linear with a regression coefficient R2 >0.9999. The limit of detection and limit of quantitation were estimated for all the five impurities. The established method was then validated for linearity, precision, accuracy, and specificity and demonstrated to be applicable to the determination of the active ingredients in commercial and model cough syrup. No interference from the formulation excipients was observed. These results suggest that this LC method can be used for the determination of multiple active ingredients and their impurities in a cough and cold syrup.

Integrated Application of Bioprocess Engineering and Biotechniques for Quality & Bulk Drug Manufacturing

“…The detector may also provide additional information related to the analyte, (i.e. UV/Vis spectroscopic data for analyte if so equipped) [31]. Analyte retention time varies depending on the strength of its interactions with the stationary phase, the ratio/ composition of solvent(s) used, and the flow rate of the mobile phase.…”

A new molecularly imprinted polymer for selective extraction and pre‐concentration of guaifenesin in different samples: Adsorption studies and kinetic modeling

“…3‐(2‐Methoxyphenoxy)propane‐1,2‐diol or guaifenesin (GUA), is a commonly used expectorant for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. GUA elevates the volume of sputum, declines the viscosity of sticky phlegm, and also used as a common ingredient in many cough/cold medications .…”

“…GUA elevates the volume of Article Related Abbreviations: EtOH, ethanol; FT-IR, Fourier transform infrared; GUA, guaifenesin; HOAc, acetic acid; IF, imprinting factor; LOD, limit of detection; LOQ, limit of quantification; MeOH, methanol; MIP, Molecularly imprinted polymer; MISPE, Molecularly imprinted solid-phase extraction; NIP, non-imprinted polymer; PBS, phosphate buffer solution; PPy, Polypyrrole. sputum, declines the viscosity of sticky phlegm, and also used as a common ingredient in many cough/cold medications [1].…”

Development and Validation of Analytical Method for Simultaneous Estimation of Bromhexine HCl and Enrofloxacine in Combined Pharmaceutical Dosage Form

“…BROM is official in IP [4] and BP [5] whereas ENR is official in USP [6]. Number of pharmacopoeial methods reported methods like UV, RP-HPLC, UV-HPTLC and LC-MS/MS methods have been developed for the estimation of BROM [7][8][9][10][11][12][13]. While Liquid Chromatography, TLC and HPLC is reported for estimation of ENR [14][15][16][17].…”