Author(s):
Vaishnavi Khairnar, Sandeep Sonawane
Email(s):
vaishukhairna2204@gmail.com
DOI:
10.52711/2231-5691.2025.00042 
Address:
Vaishnavi Khairnar1, Sandeep Sonawane2
1Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik.
2Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik.
*Corresponding Author
Published In:
Volume - 15,
Issue - 3,
Year - 2025
ABSTRACT:
Objectives: The aim of this study was to develop accurate, specific, linear, simple, rapid, precise, reliable and stability indicating RP-HPLC analytical method for the determination of Danazol in pharmaceutical dosage form. The chromatographic separation was achieved using Waters alliance e2695 HPLC system with PDA detector using appropriate mobile phase composition. On Sapphirus C18 column (250×4.6mm, 5µ) sharp peak of Danazol was obtained with Acetonitrile: water (90:10 %v/v) mobile phase composition at constant flow rate of 1mL/min. With PDA detector elutes were detected at 285nm was optimized and fixed. Linearity was performed on concentration range of 2 to 12 µg/mL with correlation factor 0.999 then the developed analytical method has been validated in terms of linearity, accuracy, precision, robustness, specificity. It was observed that validation of method proves good accuracy and precision. Danazol was subjected to stress conditions including alkaline, acidic, oxidation, photolytic, and thermal degradation. The retention time for Danazol was found to be 5.644 min. The drug was found to be more sensitive to alkaline and acidic hydrolysis and all the degradation products were found to be well separated from the principal peak.
Cite this article:
Vaishnavi Khairnar, Sandeep Sonawane. Development and Validation of Stability Indicating HPLC Method for Estimation of Anti-Gonadotropic Drug Danazol in Bulk and Capsule: Degradation Study Characterization of Alkali Degradation Product and ADME/Tox Evaluation. Asian Journal of Pharmaceutical Research. 2025; 15(3):263-8. doi: 10.52711/2231-5691.2025.00042
Cite(Electronic):
Vaishnavi Khairnar, Sandeep Sonawane. Development and Validation of Stability Indicating HPLC Method for Estimation of Anti-Gonadotropic Drug Danazol in Bulk and Capsule: Degradation Study Characterization of Alkali Degradation Product and ADME/Tox Evaluation. Asian Journal of Pharmaceutical Research. 2025; 15(3):263-8. doi: 10.52711/2231-5691.2025.00042 Available on: https://www.asianjpr.com/AbstractView.aspx?PID=2025-15-3-6
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