Taylor & Francis
Journal of Liquid Chromatography and Related Technologies
,  volume 38 ,  issue 10 ,  pages 1014-1025

HPLC Method for Simultaneous Determination of Potential Impurities of Norgestimate and Ethinyl Estradiol in Combination Drug Product Using Sub-2 µm Column

Bhaskara P V Mantena 1
, 
Sumathi V Rao 1
, 
K M Ch Appa Rao 2
, 
K. RAMAKRISHNA 2
, 
S P Vittal 1
1
 
APL Research Centre (A Division of Aurobindo Pharma Limited), Hyderabad, Telangana, India | 
2
 
Publication type: Journal Article
Publication date: 2015-04-29
Taylor & Francis
scimago Q3
wos Q4
SJR: 0.240
CiteScore: 2.2
Impact factor: 1.2
ISSN: 10826076, 1520572X
Biochemistry
Pharmaceutical Science
Clinical Biochemistry
Analytical Chemistry
Abstract
This paper describes a strategic development and validation of stability-indicating high-performance liquid chromatography (HPLC) method for the determination of potential impurities present in highly potent and low dose combination drug product of Norgestimate and Ethinyl estradiol tablets. Effective and faster separation of impurities from the drug products was achieved on a sub-2 µm fused core particle C8 column (150 mm × 4.6 mm i.d.) using water and acetonitrile as mobile phase in gradient pump mode. Flow rate was selected 1.0 mL/min with a detection quantification wavelength of 230 nm. The calibration curve obtained from linearity data (r > 0.995) in the relevant ranges (up to 150% of the expected concentration of the analytes in the test concentration), accuracy (>95% recovery for the impurities of respective analytes), method precision and intermediate precision (RSD < 5.0%), specificity (purity is less than purity threshold for all potential impurities present in respective drug components), and m...
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GOST |
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GOST Copy
Mantena B. P. V. et al. HPLC Method for Simultaneous Determination of Potential Impurities of Norgestimate and Ethinyl Estradiol in Combination Drug Product Using Sub-2 µm Column // Journal of Liquid Chromatography and Related Technologies. 2015. Vol. 38. No. 10. pp. 1014-1025.
GOST all authors (up to 50) Copy
Mantena B. P. V., Rao S. V., Rao K. M. C. A., RAMAKRISHNA K., Vittal S. P. HPLC Method for Simultaneous Determination of Potential Impurities of Norgestimate and Ethinyl Estradiol in Combination Drug Product Using Sub-2 µm Column // Journal of Liquid Chromatography and Related Technologies. 2015. Vol. 38. No. 10. pp. 1014-1025.
RIS |
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RIS Copy
TY - JOUR
DO - 10.1080/10826076.2014.962149
UR - https://doi.org/10.1080/10826076.2014.962149
TI - HPLC Method for Simultaneous Determination of Potential Impurities of Norgestimate and Ethinyl Estradiol in Combination Drug Product Using Sub-2 µm Column
T2 - Journal of Liquid Chromatography and Related Technologies
AU - Mantena, Bhaskara P V
AU - Rao, Sumathi V
AU - Rao, K M Ch Appa
AU - RAMAKRISHNA, K.
AU - Vittal, S P
PY - 2015
DA - 2015/04/29
PB - Taylor & Francis
SP - 1014-1025
IS - 10
VL - 38
SN - 1082-6076
SN - 1520-572X
ER -
BibTex |
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BibTex (up to 50 authors) Copy
@article{2015_Mantena,
author = {Bhaskara P V Mantena and Sumathi V Rao and K M Ch Appa Rao and K. RAMAKRISHNA and S P Vittal},
title = {HPLC Method for Simultaneous Determination of Potential Impurities of Norgestimate and Ethinyl Estradiol in Combination Drug Product Using Sub-2 µm Column},
journal = {Journal of Liquid Chromatography and Related Technologies},
year = {2015},
volume = {38},
publisher = {Taylor & Francis},
month = {apr},
url = {https://doi.org/10.1080/10826076.2014.962149},
number = {10},
pages = {1014--1025},
doi = {10.1080/10826076.2014.962149}
}
MLA
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MLA Copy
Mantena, Bhaskara P. V., et al. “HPLC Method for Simultaneous Determination of Potential Impurities of Norgestimate and Ethinyl Estradiol in Combination Drug Product Using Sub-2 µm Column.” Journal of Liquid Chromatography and Related Technologies, vol. 38, no. 10, Apr. 2015, pp. 1014-1025. https://doi.org/10.1080/10826076.2014.962149.