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Development and Validation of Rp-hplc Method for the Estimation of Alogliptin in Api and Tablet Formulation


Affiliations
1 D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
     

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The analytical method was developed and validated for determination of Alogliptin in bulk and pharmaceutical dosage forms by High performance liquid chromatography. The separation was carried out on Zorbax SB-Aq (250 x4.6mm,5μ ID) column. The mobile phase consists of 0.1% TFA Water : ACN in the ratio 62:38 at flow rate 1ml/min with diode array detector wavelength at 290nm.The column temperature was adjusted at 30º ± 0.5°C with injection volume 10μl.The retention time of Alogliptin was 3.06min. The linearity of the calibration curve was linear over the concentration range 25-75μg/ml (r2=1). The validation was carried out as per ICH guidelines. The development of method was easy, rapid, linear, precise, accurate and consistent.

Keywords

Alogliptin, RP-HPLC, Validation, Method development, 290nm and diode array detector.
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  • Development and Validation of Rp-hplc Method for the Estimation of Alogliptin in Api and Tablet Formulation

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Authors

Suyash Ingle
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
Varsha Tegeli
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
Avinash Birajdar
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
Gajanand Nangare
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India

Abstract


The analytical method was developed and validated for determination of Alogliptin in bulk and pharmaceutical dosage forms by High performance liquid chromatography. The separation was carried out on Zorbax SB-Aq (250 x4.6mm,5μ ID) column. The mobile phase consists of 0.1% TFA Water : ACN in the ratio 62:38 at flow rate 1ml/min with diode array detector wavelength at 290nm.The column temperature was adjusted at 30º ± 0.5°C with injection volume 10μl.The retention time of Alogliptin was 3.06min. The linearity of the calibration curve was linear over the concentration range 25-75μg/ml (r2=1). The validation was carried out as per ICH guidelines. The development of method was easy, rapid, linear, precise, accurate and consistent.

Keywords


Alogliptin, RP-HPLC, Validation, Method development, 290nm and diode array detector.

References