Validated Stability-indicating RP-HPLC Method for Analysis of Azelaic Acid in Pharmaceuticals (Record no. 8022)

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control field 20190314114423.0
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fixed length control field 181227b xxu||||| |||| 00| 0 eng d
040 ## - CATALOGING SOURCE
Original cataloging agency AIKTC-KRRC
Transcribing agency AIKTC-KRRC
100 ## - MAIN ENTRY--PERSONAL NAME
9 (RLIN) 7259
Author Malik, D. S.
245 ## - TITLE STATEMENT
Title Validated Stability-indicating RP-HPLC Method for Analysis of Azelaic Acid in Pharmaceuticals
250 ## - EDITION STATEMENT
Volume, Issue number Vol. 80(03), September-October
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Mumbai
Year 2018
Name of publisher, distributor, etc. Indian Journal of Pharmaceutical Science
300 ## - PHYSICAL DESCRIPTION
Pagination 503-509
520 ## - SUMMARY, ETC.
Summary, etc. The study is designed to develop a simple, rapid, selective and robust stability indicating reversed phase-high performance liquid chromatography method for quantitative analysis of azelaic acid in pharmaceutical preparations. The chromatographic separation and estimation of azelaic acid was carried out using a Waters high performance liquid chromatography system employing Kromasil 100-5C18 column (250×4.6 mm; 5 µm particle size) as a stationary phase. The mobile phase comprised of 75 volumes of sodium di-hydrogen orthophosphate (pH 3.5; 50 mM) and 25 volumes of acetonitrile, eluted at a flow rate of 1.2 ml/min. The eluents were monitored at 206 nm using 2487 dual wavelength ultra violet detector. The method was developed and validated in terms of stability as per International Conference on Harmonisation and Center for Drug Evaluation and Research guidelines. A linear relationship between peak area and concentration of azelaic acid was observed in a concentration range of 5-400 µg/ml (correlation coefficient, r2= 0.998). The method showed acceptable levels of precision (%RSD ≤2), accuracy (>96 % recovery), robustness (<10 % content difference) and stability (>96 % recovery) over varied environmental and laboratory conditions. The method was successfully applied for the determination of azelaic acid, extracted from three different batches of Aziderm® cream, which yielded a recovery of >97 %, indicated its applicability in routine analysis of azelaic acid in pharmaceutical preparations.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
9 (RLIN) 4639
Topical term or geographic name entry element PHARMACEUTICS
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Keywords Non-derivatized
700 ## - ADDED ENTRY--PERSONAL NAME
9 (RLIN) 7260
Co-Author Kaur, G.
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Place, publisher, and date of publication New Delhi Indian Pharmaceutical Association
International Standard Serial Number 0250-474X
Title Indian journal of pharmaceutical sciences
856 ## - ELECTRONIC LOCATION AND ACCESS
Link text Click here
URL http://www.ijpsonline.com/articles/a-validated-stabilityindicating-rphplc-method-for-analysis-of-azelaic-acid-in-cosmeceuticals-3492.html
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          School of Pharmacy School of Pharmacy Archieval Section 2019-03-29 2018357 2019-06-19 2019-03-29 Articles Abstract Database
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