Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method

Vyas, Amitkumar J.; Gol, Dhruvanshi A.; Patel, Ashok B.; Patel, Nilesh K.; Chavda, Jayant; Lumbhani, Arvind; Chudasama, Alpesh

doi:10.1080/22297928.2021.1938215

Cited by 14 publications

(1 citation statement)

References 12 publications

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“…Dapagliflozin propanediol monohydrate is an SGLT-2 inhibitor and treats type-2 diabetes mellitus (1). Analytical quality by design (AQbD) and CCD help in regulatory compliance for RP-HPLC method development, stress testing, or stability-indicating methods (3)(4)(5)(6). UV spectrophotometric methods (simultaneous equation method/ Vierodt') and LC-MS are widely acceptable for the simultaneous estimation of pharmaceutical combinations (7)(8)(9).…”

Section: Introductionmentioning

confidence: 99%

Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

HITEKSHA,

CHOTALİYA

2023

Journal of the Turkish Chemical Society Section A: Chemistry

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For the quantitative measurement of Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate in synthetic mixture form in the presence of its degradants, precise, accurate, robust, cost-effective, and isocratic stability indicating RP-HPLC method was developed and validated. The mobile phase comprises [Methanol: 20 mM Ammonium formate (70:30 v/v)] at a flow rate of 1.0 ml/min, injection volume of 20 µl, and UV detection at 225 nm. Separation was accomplished using Gemini, C18 column. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate were eluted with retention times of 6.65 minutes and 4.20 minutes, respectively. This procedure was approved following ICH guideline Q2 (R1). The calibration plots for Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate have correlation coefficients of 0.9995 and 0.9996 over the concentration ranges of 5-100 µg/ml and 10-200 µg/ml respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, accuracy ranged from 99.81-100.78% and 99.13-100.69%, respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, the LOD was found to be 0.947 µg/ml and 1.355 µg/ml. In contrast, the LOQ was 2.869 µg/ml and 4.107 µg/ml, respectively. The findings demonstrated the applicability of the devised approach for routine analysis of Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate in a synthetic mixture form with its degradants.

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