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Cited by 40Analytical Methods in PharmaceuticalsAnalytical Chemistry and ChromatographyOptimal Experimental Design Methods

Application of Experimental Design and Response Surface Technique for Selecting the Optimum RP HPLC Conditions for the Determination of Moxifloxacin HCl and Ketorolac Tromethamine in Eye Drops

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Kalariya, Pradipbhai D., Namdev, Deepak, Srinivas, R., Gananadhamu, S.·2017·Journal of Saudi Chemical Society
DOI 10.1016/j.jscs.2014.04.004
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Abstract

A method has been developed for the separation of moxifloxacin HCl and ketorolac tromethamine using reverse phase high-performance liquid chromatography (RP-HPLC) on C18 column (250 × 4.6 mm, 5 μm) with UV detection at 308 nm. Experimental designs were applied for multivariate optimization of the experimental conditions of RP-HPLC method. Three independent factors: methanol content in the mobile phase composition , buffer pH and flow rate were used to design mathematical models. Here faced central composite (FCC) experimental design was used to study the response surface technique and to study in depth the effects of these independent factors. Derringer’s desirability function was applied to simultaneously optimize the retention time of last eluting peak (ketorolac tromethamine) and tailing factor of moxifloxacin . The predicted optimum assay condition consisted of methanol and potassium dihydrogen phosphate buffer (pH 3.2; 25 mM, 0.5% Triethylamine) in a proportion of 60:40% v/v, respectively, as the mobile phase at a flow rate of 1.2 mL min − 1 . Using this optimum condition, baseline separation of both drugs with good resolution and a run time of less than 7 min were achieved. The optimized assay condition was validated according to ICH guidelines to confirm specificity, linearity, accuracy and precision.

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Cited by

Sorted by citations

Authors
Kalariya, P. D., Namdev, D., Srinivas, R., & Gananadhamu, S.
Affiliations
National Institute of Pharmaceutical Education and Research (IN)
ORCID
Srinivas, R.
Venue
Journal of Saudi Chemical Society
Publisher
Springer Science and Business Media LLC
Published
2017-01
Volume
21
Pages
S373-S382
ISSN
1319-6103 (ISSN-L)
DOI
10.1016/j.jscs.2014.04.004
OpenAlex
W1969395353
Cited by
40
References
0
Citations by year
2025: 2 · 2024: 4 · 2023: 3 · 2022: 7 · 2021: 2 · 2020: 5 · 2019: 8 · 2018: 4 · 2017: 4 · 2016: 1
FWCI
1.49
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Saudi Chemical Society (publishedVersion, cc-by-nc-nd)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
  • Physical Sciences › Chemistry › Analytical Chemistry › Analytical Chemistry and Chromatography
  • Social Sciences › Decision Sciences › Management Science and Operations Research › Optimal Experimental Design Methods
Keywords
moxifloxacin hydrochloride, ketorolac tromethamine, eye drops, RP-HPLC method optimization, response surface methodology, central composite design, Derringer desirability function, mobile phase composition, retention time, tailing factor, pharmaceutical analysis

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