2nd International Conference on Fostering Interdisciplinary Research In Health Sciences (ICFIRHS) 2019 (01-May-2019)        |

Journal :   Research Journal of Pharmacy and Technology

Volume No. :   11

Issue No. :  10

Year :  2018

Pages :   4487-4491

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Development and validation of a new stability indicating ultrafast liquid chromatographic method for the determination of Exemestane tablets



Address:   Gujju Hima Bindu*, Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy,
GITAM (Deemed to be University, Visakhapatnam-530045, India
*Corresponding Author
DOI No: 10.5958/0974-360X.2018.00821.1

ABSTRACT:
Exemestane is an irreversible steroidal aromatase inactivator. Exemestane is used for postmenopausal women who are suffering with estrogen receptor positive early breast cancer as an adjuvant treatment. A new stability indicating ultrafast liquid chromatographic method was developed and validated for the determination of Exemestane. Shimadzu Model UFLC system with PDA detector was used for the present study. Mobile phase consisting of tetra butyl ammonium hydrogen sulphate and acetonitrile (30: 70, v/v) was used with a flow rate of 1.2 mL/min (Detection wavelength 250 nm). Exemestane shows linearity 0.5–100 µg/mL with linear regression equation y = 62584 x + 599.1 (R2 = 0.9999). The LOD and LOQ were found to be 0.1401 and 0.4348 µg/mL. Stress degradation studies were performed and method was validated as per ICH guidelines.
KEYWORDS:
UFLC, Exemestane, Validation, Stability-indicating, ICH guidelines.
Cite:
Gujju Hima Bindu, Mukthinuthalapati Mathrusri Annapurna. Development and validation of a new stability indicating ultrafast liquid chromatographic method for the determination of Exemestane tablets. Research J. Pharm. and Tech 2018; 11(10): 4487-4491.
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