Application of HPTLC for simultaneous estimation of ambroxol hydrochloride and roxithromycin in pharmaceutical dosage forms

A simple, rapid and reliable HPTLC method was developed for the determination of Ambroxol Hydrochloride and Roxithromycin in tablets. Stress testing and stability studies were carried out for both the drugs as per the ICH guidelines. Determinations were performed on aluminium backed silica gel 60 F₂₅₄ HPTLC plates, with conc. Ammonia, 1-propanol,ethylacetate, hexane 0.5+20+20+70(v/v), as mobile phase. The validated calibration range was 300ng - 1500ng spot^-1 (r = 0.998) and 750 ng - 3750 ng (r = 0.997) for Ambroxol Hydrochloride and Roxithromycin respectively. The spots were scanned at λ = 254nm. The suitability of this HPTLC method for quantitative determination of compounds was proved by various validation parameters in accordance with the requirements of ICH guidelines (Q2B). Results from the stress testing studies indicated in the present research paper will form an integral part the development of new pharmaceutical formulations of Ambroxol hydrochloride and Roxithromycin and their estimation in biological fluids.