Development and validation of a high-performance liquid chromatographic stability-indicating method for the analysis of Synercid® in quality control, stability and compatibility studies

1999 ◽  
Vol 19 (5) ◽  
pp. 641-657 ◽  
Author(s):  
Blandine Vasselle ◽  
Gabriel Gousset ◽  
Jean-Paul Bounine
Keyword(s):  
Quality Control ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Compatibility Studies ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Control Stability ◽  
Development And Validation ◽  
Liquid Chromatographic

scholarly journals Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC

2015 ◽  
Vol 51 (3) ◽  
pp. 653-661 ◽  
Author(s):  
Priyanka S. Jadhav ◽  
Priti M. Jamkar ◽  
Amelia M. Avachat
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Atorvastatin Calcium ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic

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.

Sign in / Sign up

Export Citation Format

Share Document