Abstract :
This research describes the stability indicating RP-HPLC method in pharmaceutical tablet dosage forms for simultaneous estimation of Levocetirizine dihydrochloride (LEV) and Montelukast Sodium (MON). The proposed RP-HPLC method was developed using separation module Waters 2695 with PDA detector and chromatographic separation was performed at a flow rate of 1 mL / min using column Hypersil BDS C18 (250/4.6 mm, 5 ?m) with a run time of 10 min. The mobile phase consisted of a 40:60% v / v Phosphate buffer and acetonitrile, pH with orthophosphoric acid was adjusted to 7.0 and the eluents were scanned at 230 nm using a PDA detector. Retention times for LEV and MON were 3.06 min, and 6.76 min, respectively. A linearity response was observed with a concentration range of 12.56–37.68 ?g / mL for LEV and 23.78–71.20 ?g / mL for MON. Limit of detection and limit of quantification for LEV are 0.079?µg/mL and 0.239?µg/mL and for MON are 0.156?µg/mL and 0.473?µg/mL, respectively. The stability indicating method was developed by subjecting the drugs to stress conditions such as acid, base hydrolysis, oxidation, neutral, photo- and thermal degradation, and the degraded products produced from the samples were successfully solved.
Keyword :
Levocetirizine dihydrochloride, Montelukast Sodium, RP-HPLC, stability indicating