International Journal of Drug Delivery Technology
Volume 14, Issue 1

A New Stability Indicating HPLC Method for Related Substances in Dapagliflozin

Bhagwat Chavan1*, Avinash Birajdar2, Hanumant Bhusnar3, Jayadeep Yadav2, Sandip Badadhe4

1JSPM’S Jayawantrao Sawant College of Pharmacy and Research, Hadapsar, Pune, Maharashtra, India.

2Dinesh Bembade College of Pharmacy, Mahalangra, Chakur, Latur, Maharashtra, India.

3Endo India Par Formulation, Mumbai, Maharashtra, India.

4Abasaheb Kakade College of B Pharmacy Bodhegaon, Dist. Ahmednagar, Maharashtra, India.

Received: 08th January, 2024; Revised: 09th February, 2024; Accepted: 24th February, 2024; Available Online: 25th March, 2024

ABSTRACT

The requirements established by the International Council for Harmonization (ICH) for the measurement of dapagliflozin from tablets were satisfied by the development and successful implementation of an reversed-phase high performance liquid chromatography (RP-HPLC) technique that is characterized by its speed, precision, and accuracy. In order to separate the samples, an isocratic mode was used on a Princeton C18 column that was operating at a flow rate of 1-mL per minute. The phase was composed of acetonitrile and 0.1% triethylamine in a volume-to-volume ratio of 50:50, with a pH of 5.0 and a detection wavelength of 224 nm. 5.163 minutes was the retention time that was determined to be best under the circumstances of the chromatographic analysis. Based on the correlation value of 0.999, it can be concluded that the procedure adhered to Beer-Lambert’s law within the measurement range of 10 to 70 μg/mL. The findings not only verified the claim that was made on the label, but they also validated the mean percent drug concentration that was specified for the commercial tablet formulation, which was 100.57%. Following the completion of an investigation, it was discovered that the approaches that were proposed have sufficient proportions of precision measurements, robustness, accuracy, range, and linearity. As part of the technique for stress testing, a number of criteria were evaluated and evaluated overall. The elements that were considered to be among these were light, humidity, temperature, oxidation, and pH (acid/base).

Keywords: Development, Validation, Stability-indicating, Evaluation services are provided for RP-HPLC, Dapagliflozin. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.53

How to cite this article: Chavan B, Birajdar A, Bhusnar H, Yadav J, Badadhe S. A New Stability Indicating HPLC Method for Related Substances in Dapagliflozin. International Journal of Drug Delivery Technology. 2024;14(1):367-372.

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