Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Ketorolac and Fluoromethalone in Ophthalmic Formulations

DOI:

https://doi.org/10.37285/ijpsn.2017.10.5.2

Authors

  • Nisha D Patel
  • Maitri V. Sharma
  • Bhavesh Prajapati
  • Samir K Shah

Abstract

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of ketorolac and fluorometholone in its ophthalmic formulation. ODS-BP hyperchrome C18 having 250 mm × 4.6 mm × 5µm with mobile phase composed of 0.2% Formic acid and 0.2% of TEA in water (pH adjusted to 5.0 with Formic Acid): Methanol (40:60 v/v) at flow rate of 1.0 ml/min, detection wavelength at 230 nm. The retention times of ketorolac and fluorometholone were found to be 5.164 min and 2.969 min, respectively. Linearity was established for Ketorolac and fluorometholone in the range of 80-120 μg/mL and 16-24 μg/mL respectively. The percentage recoveries for ketorolac and fluorometholone were found to be in the range of 98-99% and 98-99% respectively. The LOD and LOQ for Ketorolac was found to be 5.14 and 15.5 μg/ml, and for fluorometholone 0.72 and 2.21 respectively.  

 

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Ketorolac, Fluorometholone, Degradation, RP-HPLC, Opthalmic

Downloads

Published

2017-09-30

How to Cite

1.
Patel ND, Sharma MV, Prajapati B, Shah SK. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Ketorolac and Fluoromethalone in Ophthalmic Formulations. Scopus Indexed [Internet]. 2017 Sep. 30 [cited 2024 Nov. 19];10(5):3815-26. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/860

Issue

Section

Research Articles

References

(2013). Simultaneous Estimation of Ketorolac Tromethamine and Omeprazole by Ultraviolet Spectroscopy. IJRPS 3: 146-153.
Brunton LL, Lazo JS and Parkt KL (2010). The pharmacological basis of therapeutics; 11th ed. Goodman and Gilmans, Mc Graw Hill medical publishing, pp 1716.
Dubey SK, Duddelly S, Jangala H and Saha RN (2013). Rapid and Sensitive Reverse-Phase High-Performance Liquid Chromato-graphy Method for Estimation of Ketorolac in Pharmaceuticals Using Weighted Regression. Indian J Pharm Sci 75: 89-93.
Fan XU, Fang YU, Bei-chengshang and Gui-li XU (2007). Determination of Ketorolac in Human Plasma by HPLC. Chinese Journal of Hospital Pharmacy 27: 1-8.
Heafindal ET, Helms RA, Gourley DR and Quan DJ (2006). Textbook of Therapeutics; 8th ed. Lippincott Williams and Wilkins, pp 278.
ICH guideline Q2 (R1) (2006). Text on Validation of Analytical Procedure, Methodology International Conference on Harmonization. Geneva.
Patel R, Chauhan P and Shah SK (2013). Quntification of Ketorolac and Fluorometholone by RP-HPLC method on ophthalmic formulation. International Journal of Pharmaceutical Research 6: 56-64.
Shah J and Maheshwari DG (2014). Development and Validation of first order derivative UV Spectrophotometric method for simultaneous estimation of Fluorometholone acetate and ketorolac in ophthalmic dosage form. IJPR 6: 56-64.
Vladimirov S, Cudina O, Agbaba D and Zivanov-stakic D (1996). Spectrophotometric Determination of Fluorometholone in Pharmaceuticals Using 1,4-dihydrazinophthalazine. Analytical Letters 29: 921-927.