You are hereSTABILITY-INDICATING RP- HPLC METHOD FOR ANALYSIS OF SITAGLIPTIN IN THE BULK DRUG AND IT’S PHARMACEUTICAL DOSAGE FORM
STABILITY-INDICATING RP- HPLC METHOD FOR ANALYSIS OF SITAGLIPTIN IN THE BULK DRUG AND IT’S PHARMACEUTICAL DOSAGE FORM
Table 7: Characteristic parameters of Sitagliptin for the RPHPLC method
*Y = bx + a, where x is the concentration of compound in μg/ ml and ; Y is the peak area ; *Average of six determinations.
Forced degradation study
When establishing the stability?indicating properties of analytical methods, the intermediate degradation products should not interfere with any stage of drug analysis. The System suitability parameters of forced degradation studies are summarised in Table 8. The results from forced degradation studies are given Table 9.Chromatograms obtained from after degradation under differentstress conditions are shown in Fig: 4 – 8, respectively. No peaks co-elutedwith the drug peak, suggesting the method enabled specificanalysis of Sitagliptin in the presence of its degradationproducts.
Table 8: System suitability parameters of Sitagliptin by degradation studies
Table 9: Results from analysis of samples by the forced degradation study, showing percentage degradation of Sitagliptin
Fig. 4: Typical chromatogram obtained after degradation of Sitaglitpin under acidic conditions
Fig. 5: Typical chromatogram obtained after degradation of Sitagliptin under alkali conditions
Fig. 6: Typical chromatogram obtained after degradation of Sitagliptin under oxidising conditions
Fig. 7: Typical chromatogram obtained after degradation of Sitagliptin under photolytic conditions
Fig: 8. Typical chromatogram obtained after thermal degradation of Sitagliptin
The method developed for quantitative analysis of Sitagliptinis rapid, precise, accurate, and selective. The method was completely validated as per ICH guidelines and satisfactory results were obtained for all the characteristics tested. The method is stability-indicating and can be used to assess the stability of Sitagliptinin bulk and pharmaceutical dosage forms. The method can be conveniently used for assay of Sitagliptin in the bulk drug and in pharmaceutical dosage forms. The method can be conveniently used in quality control laboratory.
We would like thank to Granule chemicals pvt ltd, Hyderabad for providing Pure sample of Sitagliptin and also to the Principal Dr .DevalaRao.Garikapati, K.V.S.R.Siddhartha college of pharmaceutical sciences, Vijayawada for providing facilities to carry work.
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