Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method

A simple, precise and accurate method was developed and validated for analysis of Ketorolac Tromethamine in eye drop formulation. An isocratic HPLC analysis was performed on Kromosil C18 column (150 cm × 4.6 mm × 5 μm). The compound was separated with the mixture of methanol and ammonium dihydrogen...

Full description

Bibliographic Details
Main Authors: G. Sunil, M. Jambulingam, S. Ananda Thangadurai, D. Kamalakannan, R. Sundaraganapathy, C. Jothimanivannan
Format: Article
Language:English
Published: Elsevier 2017-02-01
Series:Arabian Journal of Chemistry
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1878535213000026
_version_ 1818132088533024768
author G. Sunil
M. Jambulingam
S. Ananda Thangadurai
D. Kamalakannan
R. Sundaraganapathy
C. Jothimanivannan
author_facet G. Sunil
M. Jambulingam
S. Ananda Thangadurai
D. Kamalakannan
R. Sundaraganapathy
C. Jothimanivannan
author_sort G. Sunil
collection DOAJ
description A simple, precise and accurate method was developed and validated for analysis of Ketorolac Tromethamine in eye drop formulation. An isocratic HPLC analysis was performed on Kromosil C18 column (150 cm × 4.6 mm × 5 μm). The compound was separated with the mixture of methanol and ammonium dihydrogen phosphate buffer in the ratio of 55:45 V/V, pH 3.0 was adjusted with O-phosphoric acid as the mobile phase at flow of 1.5 mL min−1. UV detection was performed at 314 nm using photo diode array detection. The retention time was found to be 6.01 min. The system suitability parameters such as theoretical plate count, tailing and percentage RSD between six standard injections were within the limit. The method was validated according to ICH guidelines. Calibrations were linear over the concentration range of 50–150 μg mL−1 as indicated by correlation coefficient (r) of 0.999. The robustness of the method was evaluated by deliberately altering the chromatographic conditions. The developed method can be applicable for routine quantitative analysis.
first_indexed 2024-12-11T08:31:16Z
format Article
id doaj.art-5b5eb9edcc684d5b88b5fbebe44c4d82
institution Directory Open Access Journal
issn 1878-5352
language English
last_indexed 2024-12-11T08:31:16Z
publishDate 2017-02-01
publisher Elsevier
record_format Article
series Arabian Journal of Chemistry
spelling doaj.art-5b5eb9edcc684d5b88b5fbebe44c4d822022-12-22T01:14:27ZengElsevierArabian Journal of Chemistry1878-53522017-02-0110S1S928S93510.1016/j.arabjc.2012.12.031Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC methodG. SunilM. JambulingamS. Ananda ThangaduraiD. KamalakannanR. SundaraganapathyC. JothimanivannanA simple, precise and accurate method was developed and validated for analysis of Ketorolac Tromethamine in eye drop formulation. An isocratic HPLC analysis was performed on Kromosil C18 column (150 cm × 4.6 mm × 5 μm). The compound was separated with the mixture of methanol and ammonium dihydrogen phosphate buffer in the ratio of 55:45 V/V, pH 3.0 was adjusted with O-phosphoric acid as the mobile phase at flow of 1.5 mL min−1. UV detection was performed at 314 nm using photo diode array detection. The retention time was found to be 6.01 min. The system suitability parameters such as theoretical plate count, tailing and percentage RSD between six standard injections were within the limit. The method was validated according to ICH guidelines. Calibrations were linear over the concentration range of 50–150 μg mL−1 as indicated by correlation coefficient (r) of 0.999. The robustness of the method was evaluated by deliberately altering the chromatographic conditions. The developed method can be applicable for routine quantitative analysis.http://www.sciencedirect.com/science/article/pii/S1878535213000026Ketorolac TromethamineRP-HPLC methodPDA detector
spellingShingle G. Sunil
M. Jambulingam
S. Ananda Thangadurai
D. Kamalakannan
R. Sundaraganapathy
C. Jothimanivannan
Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method
Arabian Journal of Chemistry
Ketorolac Tromethamine
RP-HPLC method
PDA detector
title Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method
title_full Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method
title_fullStr Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method
title_full_unstemmed Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method
title_short Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method
title_sort development and validation of ketorolac tromethamine in eye drop formulation by rp hplc method
topic Ketorolac Tromethamine
RP-HPLC method
PDA detector
url http://www.sciencedirect.com/science/article/pii/S1878535213000026
work_keys_str_mv AT gsunil developmentandvalidationofketorolactromethamineineyedropformulationbyrphplcmethod
AT mjambulingam developmentandvalidationofketorolactromethamineineyedropformulationbyrphplcmethod
AT sanandathangadurai developmentandvalidationofketorolactromethamineineyedropformulationbyrphplcmethod
AT dkamalakannan developmentandvalidationofketorolactromethamineineyedropformulationbyrphplcmethod
AT rsundaraganapathy developmentandvalidationofketorolactromethamineineyedropformulationbyrphplcmethod
AT cjothimanivannan developmentandvalidationofketorolactromethamineineyedropformulationbyrphplcmethod