Abstract
The present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of atorvastatin calcium and celecoxib, both as a bulk drug and in niosomal formulation. The analysis has been performed by using Cosmosil-C18 column (4.6 mm´250 mm, 5 m) at 25 °C using acetonitrile: ammonium acetate buffer pH 5.0: methanol (50:25:25 v/v/v) as mobile phase. The detection was carried out at 277nm with a flow rate of 1.0mL/min. The retention times of Atorvastatin calcium and Celecoxib were 6.195 and 3.989min, respectively. The method was validated according to ICH guidelines, for specificity, precision, linearity, accuracy and robustness. Atorvastatin calcium and Celecoxib were subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation was observed in oxidation and acid hydrolysis. The linearity for atorvastatin calcium and celecoxib were in the range of 100-500 µg/mL. The recovery study of atorvastatin and celecoxib were found to be in the range of 98.96 - 99.92% and 98.90-100%, respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Celecoxib in combined in-house niosomal formulation.
Highlights
Atorvastatin calcium is [R-(R*,R*)]-2-(4fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate [Figure1(a)] (IP, 2007)
Celecoxib is p-[5-p-methylphenyl-3(trifluoromethyl)-1H-pyrazol-1-yl]benzene sulfonamide [Figure 1(b)] (Moffat, c2004), it is a selective cycloxygenase-2 (PTGS2/ COX2) inhibitor used for treatment of osteoarthritis and rheumatoid arthritis
It acts by reducing prostaglandin synthesis through inhibition of COX-2
Summary
Atorvastatin calcium is [R-(R*,R*)]-2-(4fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate [Figure1(a)] (IP, 2007). Atorvastatin is a selective, competitive inhibitor of HMGCoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Celecoxib is p-[5-p-methylphenyl-3(trifluoromethyl)-1H-pyrazol-1-yl]benzene sulfonamide [Figure 1(b)] (Moffat, c2004), it is a selective cycloxygenase-2 (PTGS2/ COX2) inhibitor used for treatment of osteoarthritis and rheumatoid arthritis. It acts by reducing prostaglandin synthesis through inhibition of COX-2. Selective COX-2 inhibitors appear to provide comparable anti-inflammatory effects to conventional non-steroidal anti-inflammatory agents (NSAIDs), while avoiding serious adverse reactions, in particular, gastrointestinal toxicity observed with chronic use of NSAIDs due to COX-1(PTGS1) inhibition (Konstantinopoulos, Lehmann, 2005)
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