Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2013 Vol: 5 Issue: 9

Development and validation of HPTLC method for the simultaneous analysis of gatifloxacin and ketorolac tromethamine in eye drops

Abstract

Gatifloxacin (GATI) and Ketorolac Tromethamine (KETO) are routinely used ophthalmic dosage forms. HPTLC promotes for higher separation efficiencies, shorter analysis time, lower amounts of mobile phase, and efficient data acquisition and processing. There are various analytical methods for their estimation of GATI and KETO but till date there is no HPTLC method for their simultaneous analysis. The paper presents the development and validation of a new HPTLC method for the simultaneous analysis of Gatifloxacin (GATI) and Ketorolac Tromethamine (KETO) in bulk drugs and eye drops. Separation was performed on silica gel 60F254 plates. The mobile phase is comprised of n-butanol : toluene : tri ethyl amine (6.5:3:0.5, v:v:v). Densitometric evaluation of the separated zones was performed at 320 nm. The drugs were satisfactorily resolved with Rf values of 0.32±0.03 and 0.55±0.03 for GATI and KETO, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (200-1000 ng per spot for GATI and KETO), precision intra-day and inter-day RSD values were always less than 2 for the titled drugs, accuracy (99.45% ±5% for GATI and 99.1% ±5% for KETO) and specificity, in accordance with ICH guidelines. The proposed HPTLC method is new, accurate and precise. Therefore, it is suitable for determination of Gatifloxacin (GATI) and Ketorolac Tromethamine (KETO) in their binary mixtures for different analytical and pharmaceutical purposes.

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