Abstract
A stability indicating reversed phase ultra performance liquid chromatography (RP-UPLC) method was developed for simultaneous determination of ambroxol hydrochloride (AMB), cetirizine hydrochloride (CTZ), methylparaben (MP) and propylparaben (PP) in liquid pharmaceutical formulation. The desired chromatographic separation was achieved on an Agilent Eclipse plus C18, 1.8 μm (50 × 2.1 mm) column using gradient elution at 237 nm detector wavelength. The optimized mobile phase consists of a mixture of 0.01 M phosphate buffer and 0.1 % triethylamine as a solvent-A and acetonitrile as a solvent-B. The developed method separates AMB, CTZ, MP and PP in presence of twelve known impurities/degradation products and one unknown degradation product within 3.5 min. Stability indicating capability was established by forced degradation experiments and seperation of known and unknown degradation products. The lower limit of quantification was established for AMB, CTZ, MP and PP. The developed RP-UPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method is applied for simultaneous estimation of AMB, CTZ, MP and PP in commercially available syrup samples. Further, the method can be extended for estimation of AMB, CTZ, MP, PP and levo-cetirizine (LCTZ) in various commercially available dosage forms.
Highlights
Ambroxol hydrochloride (AMB) is semi-synthetic derivative of vasicine obtained from Indian shrub Adhatoda vasica
Methylparaben is the methyl ester of p-hydroxybenzoic acid and propylparaben is the propyl ester of p-hydroxybenzoic acid
The % RSD was 0.4 % for AMB, 0.6 % for Cetirizine hydrochloride (CTZ), 0.7 % for MP and 0.9 % for PP, which are well within the acceptance criteria of 2.0%, so this study proved that the method to be rugged enough for day to day use
Summary
Ambroxol hydrochloride (AMB) is semi-synthetic derivative of vasicine obtained from Indian shrub Adhatoda vasica. It is a metabolic product of bromhexine. It is used as broncho secretolytic and an expectorant drug [1]. Cetirizine hydrochloride (CTZ) is an orally active and selective H1-receptor antagonist. It is piperazine derivative and metabolite of hydroxyzine. Combinations of AMB with CTZ in drug formulation used as antihistaminic H1 blockers. Methylparaben and propylparaben are used as either single or in combinations in drug products as antimicrobial preservatives to prevent alteration of product preparations. Methylparaben is the methyl ester of p-hydroxybenzoic acid and propylparaben is the propyl ester of p-hydroxybenzoic acid
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