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

TLDR A reliable method was created to measure dutasteride and related molecules in capsules.

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.

View this study on doi.org →

Discuss this study in the Community →

Research cited in this study

4 / 4 results

Long-Term Dutasteride Therapy in Men with Benign Prostatic Hyperplasia Alters Glucose and Lipid Profiles and Increases Severity of Erectile Dysfunction

research Long-Term Dutasteride Therapy in Men with Benign Prostatic Hyperplasia Alters Glucose and Lipid Profiles and Increases Severity of Erectile Dysfunction

20 citations , June 2017 in “Hormone Molecular Biology and Clinical Investigation”

Long-term use of dutasteride for enlarged prostate may worsen blood sugar, cholesterol, and erectile dysfunction.

Superiority of Dutasteride Over Finasteride in Hair Regrowth and Reversal of Miniaturization in Men With Androgenetic Alopecia: A Randomized Controlled Open-Label, Evaluator-Blinded Study

research Superiority of Dutasteride Over Finasteride in Hair Regrowth and Reversal of Miniaturization in Men With Androgenetic Alopecia: A Randomized Controlled Open-Label, Evaluator-Blinded Study

33 citations , August 2016 in “Indian Journal of Dermatology, Venereology and Leprology”

Dutasteride is more effective than finasteride at increasing hair count and reversing hair thinning in men with hair loss, but both have similar side effects.

research Adverse Effects and Safety of 5-Alpha Reductase Inhibitors (Finasteride, Dutasteride): A Systematic Review

32 citations , July 2016 in “PubMed”

5-alpha reductase inhibitors are generally safe but can cause sexual side effects and require patient education on risks.

research A Method to Monitor Dutasteride in Rat Plasma Using Liquid-Liquid Extraction and Multiple Reaction Monitoring: Comparisons and Validation

7 citations , September 2014 in “Mass spectrometry letters”

The best method to monitor dutasteride in rat plasma is liquid-liquid extraction with methyl tert-butyl ether and methylene chloride.

Related Research

1 / 1 results

research Discovery and Clinical Development of Dutasteride, a Potent Dual 5α-Reductase Inhibitor

58 citations , March 2006 in “Current topics in medicinal chemistry”

Dutasteride effectively treats benign prostatic hyperplasia and may reduce prostate cancer risk.