Home About Login Current Archives Announcements Editorial Board
Submit Now For Authors Call for Submissions Statistics Contact
Home > Archives > Volume 20, No 11 (2022) > Article

DOI: 10.14704/nq.2022.20.11.NQ66074

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF ERTUGLIFLOZIN IN DOSAGE FORM

Ms. Bhumi R. Patel,Dr. Akruti Khodakiya1

Abstract

To develop precise, accurate, reproducible and validate stability indicating HPLC method for determination of Ertugliflozin in API and pharmaceutical formulation as per ICH Q2 R1 Guideline. The adequate separation was carried using Kromasil C18 column (25 cm x 0.46 cm) 5μ as a stationary phase and a mixture of 0.01M pH 5.5 KH2PO4 Buffer: ACN (70:30 v/v) as a mobile phase with the flow rate of 1.0 ml/min and the effluent was monitored at 220nm using single wavelength UV detector. A stability indicating HPLC method has been developed for analysis of the drug in the presence of the degradation products and is validated with different parameters such as linearity, Precision, Accuracy, Robustness and Specificity. It involved various time interval study in which methanol and distilled water were used as solvents. Beer’s law was obeyed in the concentration range of 5-25μg/ml. A retention time of Ertuagliflozin was5.52 min. A recovery of Ertugliflozin in tablet formulation was observed in the range of 99.83-100.13%.Degradation of Ertugliflozin was found to occur in acid, alkaline, hydrogen peroxide and thermal conditions whereas it was found to be photo stable. The proposed method was found to be specific, accurate, precise and robust can be used for estimation of Ertugliflozin in API and pharmaceutical formulation.

Keywords

Ertugliflozin, Recovery, Validation, RP-HPLC

Full Text

PDF

References

?>