ABSTRACT

The main objective of the present is to develop simple, precise, accurate and reproducible UV spectrophotometric and stability indicating HPLC methods for estimation of gatifloxacin sesquihydrate (GATI) and fluorometholone acetate (FLM) in ophthalmic dosage form. Dual wavelength spectrophotometric method, which involves solving of simultaneous equations based on the measurement of absorbance at 290 nm and 240 nm, which are the absorption maxima (?max) of GATI and FLM respectively. The HPLC analysis is carried out on Hypersil Gold C18 column (4.6 x 250 nm, 5?), using phosphate buffer (pH 3) in acetonitrile and methyl alcohol in the ratio of (60:40 v/v) as the mobile phase with a flow rate of 1.0 ml/min. The detection was carried out at a wavelength of 274 nm. The retention time were found to be 4.730 ± 0.5 min and 12.974 ± 0.5 min for GATI and FLM respectively. The percentage recoveries of both the drugs GATI and FLM were 98.6-100.5 % and 98.9- 100.4 % respectively. The linearity range were found to be 50-150% for both the drugs is <1, respectively. The value of standard deviation and % R.S.D were found to be <2%. The simultaneous estimation of GATI and FLM in ophthalmic dosage form by HPLC method were estimated and validated according to ICH guidelines. Keywords: HPLC method, gatifloxacin, fluorometholone, validation, ICH guidelines
Publication date: 01/08/2025

https://ijbpas.com/pdf/2025/August/MS_IJBPAS_2025_9349.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.8.9349