DEVELOPMENT AND STABILITY INDICATING HPLC METHOD FOR DAPAGLIFLOZIN IN API AND PHARMACEUTICAL DOSAGE FORM


Mitali V. Verma, Chirag J. Patel, M. M. Patel

Abstract


Objective: To develop precise, accurate and reproducible stability assay method by RP-HPLC for estimation of dapagliflozin in API and pharmaceutical dosage form.

Methods: The adequate separation was carried using agilent C18 (4.6 ml (millimeter)*150,5 µm (micromiter), mixture of acetonitrile: di-potassium hydrogen phosphate with pH-6.5 adjusted with OPA (40:60 %v/v) as a mobile phase with the flow rate of 1 ml/min (milliliter/minute) and the effluent was monitored at 222 nm (nanometer) using photo diode array detector. The retention time of dapagliflozin API and dapagliflozin tablet were 3.160 min (minute) and 3.067 min (minute) respectively.

Results: Linearity for dapagliflozin was found in the range of 50-150µg/ml (microgram/milliliter) (R2 = 0.99) respectively. The accuracy of the present method was evaluated at 50 %, 100% and 150%. The % recoveries of dapagliflozin API and tablet were found to be in the range of 99.00–99.99 % and 98.50–99.99 % respectively. Precision studies were carried out and the relative standard deviation values were less than two. The method was found to be robust.

Conclusion: The proposed method was found to be specific, accurate, precise and robust can be used for estimation of dapagliflozin in API and Pharmaceutical dosage form.


Keywords


HPLC, Dapagliflozin, API, Pharmaceutical dosage form, OPA

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References


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About this article

Title

DEVELOPMENT AND STABILITY INDICATING HPLC METHOD FOR DAPAGLIFLOZIN IN API AND PHARMACEUTICAL DOSAGE FORM

Keywords

HPLC, Dapagliflozin, API, Pharmaceutical dosage form, OPA

DOI

10.22159/ijap.2017v9i5.19185

Date

15-09-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 5 (Aug-Sep), 2017 Page: 33-41

Online ISSN

0975-7058

Statistics

38 Views | 32 Downloads

Authors & Affiliations

Mitali V. Verma
Department of Pharmaceutical Analysis, Gujarat Technological University, Ahmedabad, Gujarat, India
India

Chirag J. Patel
Department of Pharmaceutical Analysis, Shree Swaminarayan Sanskar Pharmacy College, Gandhinagar, Gujarat, India
India

M. M. Patel
Shree Swaminarayan Sanskar Pharmacy College, Gandhinagar, Gujarat, India
India


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