Developing and Validating an HPLC Method to Quantify Simultaneously Dutasteride and Their Related Molecules (Dutasteride Acid, 2,5 Bis-(Trifluoromethyl)-Aniline and Dutasteride 17 α-Epimer) in Capsules

January 2020 in “ International Journal of Research in Pharmacy and Chemistry ”

Pola Srinivas, Kancharlapalli Venkataramana

dutasteride dutasteride acid 2,5 bis-(trifluoromethyl)-aniline dutasteride 17 α-epimer Avodart

Studysummary This study developed a validated HPLC method for accurately estimating dutasteride and its related compounds in capsules, suitable for routine and stability sample analysis. Our plain-language summary of this paper — not a Tressless recommendation.

The study developed and validated a stability-indicating HPLC method to simultaneously estimate dutasteride and its related molecules in capsules. The method used an Inertsil ODS-3 column and a gradient elution mode with specific mobile phases. Validation followed USP and ICH guidelines, demonstrating linearity across specified concentration ranges for each compound. The method showed acceptable precision, accuracy, system suitability, ruggedness, and robustness, making it suitable for routine and stability sample analysis.

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