Volume No. :   6

Issue No. :  4

Year :  2016

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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Analytical Method Development and Validation of a Stability-indicating RP-HPLC Method for the Analysis of Danazol in Pharmaceutical Dosage Form



Address:   Kirthi A1*, Shanmugam R1, Mohana Lakshmi S2 , Ashok Kumar CK2, Padmini K3, Shanti Prathyusha M1, Shilpa V1
1Department of Pharmaceutical Analysis, Sree Vidyanikethan College of Pharmacy, Tirupati-517102, Andhra Pradesh, India.
2Department of Pharmacognosy, Sree Vidyanikethan College of Pharmacy, Tirupati-517102, Andhra Pradesh, India.
2Department of Pharmaceutical Chemistry, Sree Vidyanikethan College of Pharmacy, Tirupati-517102, Andhra Pradesh, India.
*Corresponding Author
DOI No:

ABSTRACT:
Danazol is an endocrine metabolic agent or anti gonadotropin drug. The aim of this study was to develop a 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 performed using phenomenex C18 column (150X4.6mm, 5µm) in RP-HPLC with mobile phase consisting of acetonitrile:potassium dihydrogen orthophosphate (70:30, v/v) with flow rate of 1ml/min and detection wave length at 285nm was optimized and fixed. The Danazol was properly resolved with a run time of 4.9 min. Linearity was performed for Danazol in the range of 10-120µg /ml (R2=0.9986). The percentage recovery for Danazol was found to be 98.87%-100.69%. The developed analytical method has been validated in terms of accuracy precision, specificity, linearity, and robustness which were within the acceptance limit according to ICH Q2 (R1) guidelines. Danazol was subjected to stress conditions including acidic, alkaline, oxidation, and thermal degradation and drug found to be more sensitive towards alkaline hydrolysis and all the degradation products were found to be well separated from the principal peak, which means that the Danazol peaks were highly pure in all chromatograms obtained. The results represents that the developed method was successfully employed for the routine quality control and stability analysis of Danazol in pharmaceutical dosage forms.
KEYWORDS:
RP-HPLC, Validation, Danazol, Stability indicating, ICH guidelines.
Cite:
Kirthi A, Shanmugam R, Mohana Lakshmi S , Ashok Kumar CK, Padmini K, Shanti Prathyusha M, Shilpa V. Analytical Method Development and Validation of a Stability-indicating RP-HPLC Method for the Analysis of Danazol in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2016; 6(4): 227-234.
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