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THE PHARMA REVIEW
(SEPTEMBER – OCTOBER 2020) |
Development and Validation
of HPLC Method for Estimation of Sitagliptin in Tablet
Dosage Form
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Sammi Akter1,4, Arghya Prosun Sarkar2, Md.
Taleb Hossain3, Md. Sadikuzzaman4, Bidduth Kumar Sarkar1,
Pijus Saha1 & Sukalyan Kumar Kundu1 |
Introduction: An accurate, precise and cost
effective HPLC method was developed that is not appeared
in pharmacopoeia for estimation of Sitagliptin.
Separation of the drug was achieved on a C18 column
using a mobile phase consisting of phosphate buffer and
acetonitrile in the ratio of 60: 40 (v/v). The flow rate
was 1mL/min and detection wavelength was 254 nm. The
linearity was observed in the concentration of 0.05,
0.20, 0.22, 0.25, 0.27, 0.29 mg/mL with a correlation
coefficient (R2) of 0.999. The retention time of
Sitagliptin was 5.2±0.03 min. The proposed method was
validated as per the ICH guidelines for the parameters:
Linearity, Accuracy, Precision, Robustness, Specificity
etc. This method can be employed for routine quality
control analysis of Sitagliptin in tablet dosage form.
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