UGC Approved Journal no 63975(19)
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ISSN: 2349-5162 | ESTD Year : 2014
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Published in:

Volume 5 Issue 12
December-2018
eISSN: 2349-5162

UGC and ISSN approved 7.95 impact factor UGC Approved Journal no 63975

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Published Paper ID:
JETIR1812125


Registration ID:
192592

Page Number

190-202

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Title

STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF NAPROXEN SODIUM IN PHARMACEUTICAL TABLET DOSAGE FORMS BY RP-HPLC

Abstract

A Specific, precise, accurate, linear, rugged and robust method was developed and validated for Naproxen sodium in pharmaceutical tablet dosage form in accordance with ICH guidelines and observed to be stability indicating. The optimized method was a gradient reverse phase chromatography using YMC pack ODS-AQ C18 column (150 x 4.6 mm, 3μm). The mobile phase consisted of solution-A (0.1% formic acid in water) and solution-B (0.1 % Formic acid in Acetonitrile). The flow rate was 1.0 mL/min, injection volume was 10µL, and wave length of detection was at 240 nm. The column and sample temperature was maintained at 25˚C. The run time was 25 minutes. The retention time of Naproxen sodium peak was about 6.24 minutes. The method showed linear response with correlation coefficient (r2) value of 0.9996. The method was validated for accuracy, precision, specificity, and robustness in accordance with ICH guidelines. The wide linearity range, sensitivity, accuracy and simple mobile phase showed that the method is suitable for routine analysis of Naproxen sodium in pharmaceutical tablet dosage forms.

Key Words

Naproxen sodium, Stability-indicating, RP-HPLC.

Cite This Article

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF NAPROXEN SODIUM IN PHARMACEUTICAL TABLET DOSAGE FORMS BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.5, Issue 12, page no.190-202, December-2018, Available :http://www.jetir.org/papers/JETIR1812125.pdf

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2349-5162 | Impact Factor 7.95 Calculate by Google Scholar

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 7.95 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Cite This Article

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF NAPROXEN SODIUM IN PHARMACEUTICAL TABLET DOSAGE FORMS BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.5, Issue 12, page no. pp190-202, December-2018, Available at : http://www.jetir.org/papers/JETIR1812125.pdf

Publication Details

Published Paper ID: JETIR1812125
Registration ID: 192592
Published In: Volume 5 | Issue 12 | Year December-2018
DOI (Digital Object Identifier):
Page No: 190-202
Country: -, -, - .
Area: Engineering
ISSN Number: 2349-5162
Publisher: IJ Publication


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