Development of High Performance Liquid Chromatographic Determination of Ambroxol, Roxithromycin and Serratiopeptidase in Combined Tablet Dosage Forms

The researchers devised and validated a simple, sensitive, and accurate RP-HPLC technique for the simultaneous measurement of ambroxol, roxithromycin, and serratiopeptidase in bulk and combination tablet dose form. Using a Waters HPLC system with a YMC Pack pro C18 (250 4.6 mm, 5 m particle size) column, ambroxol, roxithromycin, and serratiopeptidase were separated and quantified. The mobile phase was made up of 0.1 percent orthophosphoric acid and 60:40 v/v acetonitrile. The calibration curves for ambroxol, roxithromycin, and serratiopeptidase were linear over concentration ranges of 12-36 g/mL, 60-180 g/mL, and 6-18 g/mL, with limits of detection of 0.040 g/mL, 1.176 g/mL, and 0.127 g/mL, respectively. Recovery rates ranged from 99.57 percent to 100.24 percent for the medications tested, with relative standard deviations ranging from 0.12 percent to 0.36 percent. According to the ICH criteria, the devised approach was validated. The proposed RP-HPLC method might be utilised to analyse ambroxol, roxithromycin, and serratiopeptidase in combination tablet dosage forms at the same time.

Author(S) Details

G. Sailaja
Department of Chemistry, Singareni Collieries Women’s Degree College, Kothagudem, Khammam, Andhra Pradesh, India.

P. R. K. Veni
Department of Chemistry, Sasi Institute of Technology and Engineering, Tadepalligudem, W.G. Dist., AP, India.

B. Hari Babu
Department of Chemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India.

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