Articles Accepted

QUALITY RISK ASSESSMENT AND DESIGNED EXPERIMENTS ORIENTED SIMULTANEOUS QUANTIFICATION OF ASPIRIN AND PANTOPRAZOLE SODIUM USING DRIFTS AND UFLC-DAD METHODS
by Mr. SAGAR SUMAN PANDA, 21 Sep 2021
Co-Author(s): Ravi Kumar Venkata Varaha Bera,Chandrasekhar Patro

Systematized, rapid, and precise analytical methods are always of great importance and advantage for quality control of new drug products. Two new analytical methods were developed and validated using the multivariate approach for the simultaneous quantification of a unique combination of aspirin and pantoprazole sodium. The first method emphasizes non-destructive identification as well as quantification of aspirin (ASP) and pantoprazole (PPS) at their characteristic diffused reflectance-based infrared absorption band at 1747cm-1(-C=O) and 1303cm-1 (-S-O), respectively. The second method relies on liquid chromatographic separation using a mobile phase of acetonitrile: phosphate buffer pH 3.5 (60:40, % v/v) at a flow rate of 1.0 mL/min using a C-18 column. Diode array detection was made at 240nm. Both the methods were validated as per the recent regulatory needs of the ICH concept using the multivariate approach. These methods were fast, linear, sensitive, accurate, and precise for the purpose. Employing risk assessment revealed that analyst, number of days and number of triturations, and analyst, number of days, and column age are the risky method parameters that may influence the preciseness of results of the infrared spectroscopic and chromatographic methods, respectively. A comparison between the results of both the methods using the Students t-test revealed no significant difference to estimate both the analytes in combined dosage forms. These methods are selective and suitable for the rapid simultaneous quantification of both the analyte in bulk drugs. They may also be applied for the quantification of both the drugs in their proposed fixed-dose marketed formulation.

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