DEVELOPMENT AND VALIDATION OF TLC-DENSITOMETRIC AND HPLC METHODS FOR DETERMINATION OF OLMESARTAN MEDOXOMIL AND METOPROLOL SUCCINATE IN COMBINATION
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 6
Abstract
Rapid, accurate and sensitive methods for the identification and quantification of Olmesartan Medoxomil (OLME) and Metoprolol Succinate (METO) were developed by TLC-densitometry and HPLC at 222 nm. The first developed method was TLC-densitometry, where mixture of OLME and METO were separated on silica gel TLC 60 F254 plates using Toluene:Methanol:Glacial acetic acid (7.0:2.5:0.5 v/v/v) as mobile phase and scanning of the separated bands at 222 nm. Linearity was observed in the concentration range of 500-2500 ng/band for OLME and 500-3000 ng/band for METO. The second method was HPLC, where the mixture of OLME and METO separated on thermo scientific BDS Hypersil, C18 column (5µm p.s, 250 mm 4.6 mm), flow rate 1 mL/min. The mobile phase selected was Phosphate buffer 0.05M (pH adjusted to 3.0±0.5 with Orthophosphoric acid): Acetonitrile (60:40 v/v) with detection at 222 nm. Linearity was observed in the concentration range of 25-200 µg/mL for OLME and 25-225 µg/mL for METO. Both methods were validated according to ICH guideline and value of linearity, precision, robustness, LOD, LOQ, selectivity, recovery were found to be good in accordance with the prescribed value.
Authors and Affiliations
Sohan Chitlange , Reshma Talole , Ramesh Bhusal , Monesh Nikumbh
Keywords
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