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Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form


Affiliations
1 Shri Adichunchunagiri College of Pharmacy, B. G. Nagara, Tal Nagmangala, Dist Mandya, Karnataka, India
2 Government College of Pharmacy, Vidyanagar, Karad-415124, Dist Satara, Maharashtra, India
     

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Simple, precise, sensitive and reproducible quantitative reverse phase HPLC method has been developed for estimation of Sitagliptin phosphate in pharmaceutical dosage form. The method was carried out on a Phenomenex RP-18 (2) Column (250×4.6 mm i.d; particle size 5 μm) column with a mobile phase consisting of (60:40 v/v Acetonitrile:water) at a flow rate of 1.0 ml/min. The eluents were monitored at 272 nm. The retention time of Sitagliptin phosphate was found out to be 5.062. The developed method was validated in terms of accuracy, precision, linearity, limit of detection and limit of quantification. The proposed method can be used for the estimation of this drug in pharmaceutical dosage forms.

Keywords

Sitagliptin Phosphate, Validation, Estimation.
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  • Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

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Authors

Sachin Patil
Shri Adichunchunagiri College of Pharmacy, B. G. Nagara, Tal Nagmangala, Dist Mandya, Karnataka, India
B. Ramesh
Shri Adichunchunagiri College of Pharmacy, B. G. Nagara, Tal Nagmangala, Dist Mandya, Karnataka, India
A. R. Hareesh
Shri Adichunchunagiri College of Pharmacy, B. G. Nagara, Tal Nagmangala, Dist Mandya, Karnataka, India
Kiran Patil
Government College of Pharmacy, Vidyanagar, Karad-415124, Dist Satara, Maharashtra, India
Ashok Dhokane
Government College of Pharmacy, Vidyanagar, Karad-415124, Dist Satara, Maharashtra, India

Abstract


Simple, precise, sensitive and reproducible quantitative reverse phase HPLC method has been developed for estimation of Sitagliptin phosphate in pharmaceutical dosage form. The method was carried out on a Phenomenex RP-18 (2) Column (250×4.6 mm i.d; particle size 5 μm) column with a mobile phase consisting of (60:40 v/v Acetonitrile:water) at a flow rate of 1.0 ml/min. The eluents were monitored at 272 nm. The retention time of Sitagliptin phosphate was found out to be 5.062. The developed method was validated in terms of accuracy, precision, linearity, limit of detection and limit of quantification. The proposed method can be used for the estimation of this drug in pharmaceutical dosage forms.

Keywords


Sitagliptin Phosphate, Validation, Estimation.