700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ ReadersThis Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)
Original Articles Open Access
A simple, sensitive and reproducible Reverse phase high performance liquid chromatography (HPLC) coupled with a photodiode array detector; method was developed for the quantitative determination of related substances in API. Chromatographic separation was achieved on Hypersil ODS (125 X 4.0) mm, 5μm, and the gradient eluted with runtime, 50.0 min. The eluted compounds were monitored at 290 nm, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 40oC. The resolution of Pantoprazole and three impurities was greater than 2.0 for all pairs of components. The high correlation coefficient (r2> 0.9990) values indicated clear correlations between the investigated compound concentrations and their peak areas within the test ranges. The repeatability and intermediate precision, expressed by the RSD, were less than 10%. The accuracy evaluated by performing recovery studies via a spike method, was in the range 80.0-120.0%. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness and robustness.
To read the full article Peer-reviewed Article PDF
Author(s): Priyadarshini S Bansode Ravindra K Kamble Chetan Singh Chauhan and Sujata S Bansode
Pantoprazole sodium, Impurity, Validation, RP HPLC