International Journal of Drug Delivery Technology
Volume 14, Issue 1

Novel HPLC Method Validation for Quantification of Dapagliflozin in Bulk Drug and Formulation

Avinash Birajdar1, Bhagwat Chavan2, Sandip Badadhe3, Hanumant Bhusnar4, Jayadeep Yadav1*

1Dinesh Bembade College of Pharmacy, Mahalangra, Chakur, Latur, Maharashtra, India.

2JSPM’s Jayawantrao Sawant College of Pharmacy and Research, Hadapsar, Pune, Maharashtra, India.

3Abasaheb Kakade College of B Pharmacy Bodhegaon, Dist-Ahmednagar, Maharashtra, India.

4Endo India Par Formulation Mumbai, Maharashtra, India. 

Received: 24th November, 2023; Revised: 18th October, 2023; Accepted: 09th February, 2024; Available Online: 25th March, 2024

ABSTRACT

A new, steady, easy-to-use, and straightforward high-performance liquid chromatography (HPCL) technique was also tested to determine dapagliflozin concentration in medicinal and API forms. For the chromatographic extraction study, a Phenomenex Gemini-NX C18 Column was used. This column was filled with a mobile phase that was 70:30 v/v methanol to sodium 1-octanesulphonate. This experiment used a 20-liter syringe amount and a flow rate of 1-mL per minute. A bunch of factors were used to make sure the new method worked. The drug dapagliflozin was released at a wavelength of 203 nm after 6.5

± 0.5 minutes. A correlation coefficient (r2) of 0.9994 between 15 to 55 μg/mL shows that the planned process is linear. The theoretical plates and peak tailing were found to be 4129 and 1.03, respectively. In terms of healing, the percent accuracy that was reached was within the acceptable range of 98 to 100. New suggestions say that the regular testing of dapagliflozin in large amounts must be done using a proven method that is unique and easy to repeat. Forced breakdown tests with drugs were used to show that the proposed method is stable. The product was tested according to the steps laid out in the ICH Q2R1 Guidelines. The test looked at many chemical processes, such as oxidation, photolysis, heat stress, and acids and alkaline hydrolysis.

Keywords: Stability Indicating, HPLC, Dapagliflozin.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.45

How to cite this article: Birajdar A, Chavan B, Badadhe S, Bhusnar H, Yadav J. Novel HPLC Method Validation for Quantification of Dapagliflozin in Bulk Drug and Formulation. International Journal of Drug Delivery Technology. 2024;14(1):316-322.

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