Rapid and Sensitive Reverse-phase High-performance Liquid Chromatography Method for Estimation of Ketorolac in Pharmaceuticals Using Weighted Regression

A reliable, rapid and sensitive isocratic reverse phase high-performance liquid chromatography method has been developed and validated for assay of ketorolac tromethamine in tablets and ophthalmic dosage forms using diclofenac sodium as an internal standard. An isocratic separation of ketorolac trom...

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Bibliographic Details
Published inIndian journal of pharmaceutical sciences Vol. 75; no. 1; pp. 89 - 93
Main Authors Dubey, S, Duddelly, S, Jangala, H, Saha, R
Format Journal Article
LanguageEnglish
Published India Medknow Publications 01.01.2013
Medknow Publications and Media Pvt. Ltd
Medknow Publications & Media Pvt. Ltd
Medknow Publications & Media Pvt Ltd
Subjects
Accuracy
Analytical chemistry
Calibration
Chromatography
Drug dosages
High performance liquid chromatography
Ketorolac
Methods
Pharmacokinetics
Quality standards
Regression analysis
Research Paper
Standard deviation
Testing
India
Germany
Mumbai India
method validation
Diclofenac sodium
reverse phase high-performance liquid chromatography-PDA
ketorolac tromethamine
weighted regression
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Summary:A reliable, rapid and sensitive isocratic reverse phase high-performance liquid chromatography method has been developed and validated for assay of ketorolac tromethamine in tablets and ophthalmic dosage forms using diclofenac sodium as an internal standard. An isocratic separation of ketorolac tromethamine was achieved on Oyster BDS (150×4.6 mm i.d., 5 μm particle size) column using mobile phase of methanol:acetonitrile:sodium dihydrogen phosphate (20 mM; pH 5.5) (50:10:40, %v/v) at a flow rate of 1.0 ml/min. The eluents were monitored at 322 nm for ketorolac and at 282 nm for diclofenac sodium with a photodiode array detector. The retention times of ketorolac and diclofenac sodium were found to be 1.9 min and 4.6 min, respectively. Response was a linear function of drug concentration in the range of 0.01-15 μg/ml (R2 =0.994; linear regression model using weighing factor 1/x2 ) with a limit of detection and quantification of 0.002 μg/ml and 0.007 μg/ml, respectively. The % recovery and % relative standard deviation values indicated the method was accurate and precise.
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ISSN:0250-474X
1998-3743
DOI:10.4103/0250-474X.113535