Impurity Summarizing on Rosiglitazone by RP-HPLC Analytical Method
*Corresponding Author E-mail: firstname.lastname@example.org
The drug analysis theatres a very dynamic role in the drug development, manufacturing and therapeutic use. The pharmaceutical industries mainly rely on the quantitative analysis to ensure that those raw materials and the final product obtained meets the essential specifications. The day by the new molecules or new formulation are increasing either a new entities or a synthetic form. There is even much more increasing the number of impurities in the drugs moieties. Now a days not just only purity profile but also impurity profile is also become a further popular as per various regulatory body like International conference on harmonization (ICH), Therapeutic good administration (TGA), US food and drug administration (USFDA). Rosiglitazone is an antidiabetic drug and thiazolidinedione class. The 2, 4 TD is the basic reactant impurity in the Rosiglitazone drug. The analytical method HPLC is to separate compounds that are dissolved in solution. In this experiment the separation was carried out on Phenomenex® C18 (250 x 4.6 mm i.d., 5μ), Column having particle size 5 μ using water and Acetonitrile in ratio of 50: 50 in gradient mode at the flow rate of 1 ml/minute. And the wavelength of the detection was 288 nm. The retention time for Rosiglitazone and 2, 4Thiazolidinedione was 4.942min and 3.092min respectively. Analytical validation parameter such as selectively, specificity, linearity, accuracy and precision were evaluated. The assay studies were carried out 6 times and the percentage relative standard deviation (%RSD) of the percentage recovery were calculated and presented in table for Rosiglitazone and 2, 4 Thiazolidinedione. from the data obtained, the amount of Rosiglitazone were found 99.12% to 99.32% w/w in the bulk drug and marketed formulation respectively. The 2, 4Thiazolidinedione were present 0.7821 μg/gm and 0.6531 μg/gm in the bulk drug and formulation respectively. Thus, the developed RP-HPLC method was found to be suitable for the estimation of impurities in Rosiglitazone.
Rosiglitazone drug (ROS), 2, 4 Thiazolidinedione (2, 4 TD), acetonitrile, Phenomenex® C18, RP-HPLC, validation.