TWO DIFFERENT CHROMATOGRAPHIC METHODS FOR SIMULTANEOUS DETERMINATION OF COMMON COLD DRUGS AMBROXOL HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, LEVOCETERIZINE DIHYDROCHLORIDE AND DESLORATADINE, IN PURE FORMS, AND IN PHARMACEUTICAL DOSAGE FORMS.

Document Type : Original Article

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National organization for drug control and Research (NODCAR)

Abstract

Two chromatographic methods were developed for simultaneous determination of some drugs used in common cold. First method  is TLC-Densitometric method for the simultaneous estimation of Ambroxol hydrochloride (AMB), Pseudoephedrine hydrochloride (PSE) and Desloratadine (DES) in pure form and in pharmaceuticaldosage form, the best resolution was obtained by the use of mobile phase (Ethyl acetate: methanol: ammonia), (14: 0.8: 0.5, v/v/v), the scanning of spots was performed at 254 nm in concentration range (1-40 ug/spot), (5-35 ug/spot),(0.2-2) ug/spot for AMB, PSE and DES, respectively. With LOD 0.262, 0.358 and 0.006 ug/ml. And LOQ 0.793, 1.09 and 0.018 ug /ml  for AMB, PSE and DES,  respectively. Second method is HPLC-UV Method for the Simultaneous determination of Ambroxol hydrochloride(AMB),Pseudoephedrine hydrochloride(PSE), Desloratadine (DES) and levoceterizine dihydrochloride (LVC) in quaternary mixture by using mobile phase consisted of acetonitrile: 0.01 M phosphate buffer (PH 5.5) (50:50, v/v) in an isocratic mode through inertsil C8 (250mm x 4.6mm, 5 µ) column at a flow rate of 1.3 ml/min. UV detection was carried out at 215 nm in concentration range (1.6-40), (3.2-40) , (0.6-9), (2.4-8.4 ) ug/ml for AMB, PSE , DES and LVC, respectively .With LOD 0.428, 0.180, 0.125 and 0.124, ug/ml And LOQ 1.299 , 0.550, 0.379, and 0.375ug/ml for AMB, PSE , DES and LVC, respectively  The validation of the proposed methods was done according to ICH guidelines.

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