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

CONCLUSION
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.

ACKNOWLEDGEMENT
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.

REFERENCES
1.    Available on drugbank.ca
2.    Available on sitgapltin.in
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4.    Monika.N, Ravipratap.P, HarshiniShabad. New extractive method development of Sitagliptin Phosphate in API and its Dosage forms by spectrophotometry. International Journal of Pharmacy and Biological sciences.2278-3008vol-1,Issue 6(July-August 2012) Pg:37-40.
5.    Swati Kupkar, ShailajaYadhav.Simultaneous estimation of Sitagliptin and Metformin hydrochloride in Bulk and Dosage forms by U.V-Spectrophotometry. International Journal of Pharmacy Research 2012,5(1),580-582.
6.    Sheetal Sharma, NimitaManocha, PriyaBhandari. Development of U.V.Spectrophotometry and RP-HPLC method and its validation for simultaneous estimation of Sitagliptin phosphate and simvastatin in marketed formulation. International Journal of Pharmaceutical and Biological Archieves 2012; 3(3):pg:673-678
7.    Mohamed Salim, Nehed EI-Enany, FathallahBelah. Simultaneous determination of Sitagliptin and Metformin in pharmaceutical preparations by Capillary Zone electrophoresis and its application to Human plasma analysis. Analytical chemistry Insights 2012:731-46.
8.   Phaneemdra.D,V.Venkatesh. Simultaneous estimation of  Simvastatin and Sitagliptin by different Analytical methods .International Journals of Advances in Pharmaceutical Analysis.vol-2, Issue 1. 589,No1(2012)
9.    ICH, Q2A Text on validation of analytical procedures, Oct, 1994.
10.     ICH, Q3B Validation of analytical procedures: methodology,Nov, 1996.

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