A Validated High Performance Liquid Chromatography Method for the Simultaneous Analysis of Guaifenesin, Ambroxol and Loratidine in Bulk and Liquid Dosage form

Abstract

A simple and sensitive HPLC method for simultaneous quantification of guaifenesin, ambroxol and loratidine in bulk and liquid dosage form was developed and fully validated. The separation and quantification was performed using a Kromasil C8 (250 × 4.6 mm, particles 5 μm) HPLC column. Isocratic elution mode with a flow rate of 1.2 mL/min was used, and the injection volume was 10 µL. The detector was set to a wavelength of 290 nm and the column oven was maintained at 30 °C. Orthophosphoric acid (0.1%) and acetonitrile in the ratio of 60:40 v/v was used as the mobile phase. Guaifenesin, ambroxol and loratidine were eluted with retention time of 3.045 min, 5.489 min and 13.981 min, respectively. The method was validated in accordance with ICH guidelines and the results of all the validation parameters were found to be within the acceptable limits. The calibration plots were linear over the concentration ranges from 50-150 µg/mL, 30-90 µg/mL and 5-15 µg/mL for guaifenesin, ambroxol and loratidine, respectively. Developed method was successfully applied for the quantification of the above three drugs in liquid dosage form. The excipient did not interfere with drug peaks.

Stress Degradation Studies and Development of Stability Indicating Assay Method for Simultaneous Estimation of Ambroxol Hydrochloride and Salbutamol Sulphate in Bulk and Its Formulation

“…It stimulates the transportation of theviscous secretion in the respiratory organs and reduces the stand stillness of the secretion. It is also anti-inflammatory, reducing redness in a sore methods were reported [9][10][11][12][13][14][15] . The object of the present work was to develop and validate a simple, economic, rapid, precise, isocratic method with good sensitivity for simultaneous determination of AMBR and SALB in accordance with ICH guideline.…”

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“…The chemical structure of desloratadine is shown in the Figure. It is used to treat chronic inflammatory pulmonary conditions, tracheobronchitis, emphysema and asthma. Literature survey reveals that ambroxol can be estimated by Spectrophotometric method [8][9][10][11][12], HPLC method [13][14][15] either alone or in combination with other drugs. The chemical structure of ambroxol is shown in the Figure. Pseudoephedrine is chemically known as (1S,2S)-2-(methylamino)-1-phenylpropan-1-ol.…”