Development and validation of an high-performance liquid chromatographic, and a ultraviolet spectrophotometric method for determination of Ambroxol hydrochloride in pharmaceutical preparations

Abstract

A high-performance liquid chromatographic (HPLC) and ultraviolet (UV) methods were developed and validated for the quantitative determination of Ambroxol hydrochloride (AMH) in pharmaceutical dosage form. HPLC was carried out by reversed phase (RP) technique on an RP-18 column with a mobile phase composed of acetonitrile and water (pH 3.5 adjusted with orthophosphoric acid [60:40, v/v]). UV method was performed with the λmax at 250 nm. Both the methods showed good linearity, reproducibility, and precision. No spectral or chromatographic interferences from the tablet excipients were found in UV and HPLC. The method was successfully applied to commercial tablets. Validation parameters such as linearity, precision, accuracy, and specificity were determined. The HPLC Limit of detection (LOD) and Limit of quantification (LOQ) for Ambroxol were found to be 1 and 5 ng/ml, respectively. The UV LOD and LOQ for Ambroxol were found to be 1 and 4 μg/ml, respectively. The results were statistically compared using one-way analysis of variance. The proposed economical method could be applicable for routine analysis of AMH and monitoring of the quality of marketed drugs.

Determination of the purity of pharmaceutical reference materials by 1 H NMR using the standardless PULCON methodology

“…A commonly applied analytical method for the quantification of this compound is HPLC with photodiode array detector [37][38][39][40].…”

SERS detection of expired tetracycline hydrochloride with an optical fiber nano-probe

“…The metabolic proling and metabolic ngerprinting applications can be addressed as well as pharmacodynamic and pharmacokinetic issues from model organisms, animals and humans. 10 HPLC, [11][12][13] LC-MS and LC-MS/MS 14 methods were applied to the drug analysis in various biological matrices for the pharmacokinetic mechanism. These methods are timeconsuming and labor-intensive for the therapeutic application.…”

Chemical and physical stability of selected drugs for aerosol therapy with Sirmione thermal water

“…This study aims to evaluate the stability in aerosol containers of two mucolytic agents, N-acetylcysteine (300 mg/3 ml) and ambroxol (15 mg /2ml), and two corticosteroids beclomethasone dipropionate (800 μg /2ml) and budesonide (0.50 mg /2ml and 0.25 mg /2ml), after dilution with Sirmione thermal water stored in plastic ampoules, for aerosol therapy. A large number of analytical methods for the determination and quantifi cation of N-acetylcysteine [11,12], ambroxol [13,14], budesonide [15] and beclomethasone dipropionate [16,17] in pharmaceutical preparations have been developed. However, in spite of the structural diversity and different chemical-physical properties of these drugs (Figure 1), mainly due to the presence of excipients (sodium edetate, polysorbate 80, polysorbate 20, and sorbitan laurate) that can interfere with the separation process, no method was found for their simultaneous analysis.…”