Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF LEVOFLOXACIN IN MARKETED FORMULATION USING HYDROTROPY

Bhumika Amliyar*, Ankit Diwan, Ganesh Patel, Dr. Kuldeep Ganju

ABSTRACT

Levofloxacin was a light yellow odorless amorphous powder melts on 224-225oC. Levofloxacin was slightly soluble in water and 0.2 N NaOH, soluble in ethanol and methanol and freely soluble in chloroform and Glacial acetic acid. UV scanning between 200-400 nm λ max of Glacial acetic acid was found at 286 nm. FT-IR spectrogram of Levofloxacin also confirm the structure by showing characteristic peaks at 3203 (COO-Hstr) and 1640 (C=O). Analytical method development by U.V spectrophotometer was started with selection of hydrotropes to enhancement of solubility of drug by solubiliztion. Increased solubility with different hydrotropes was found as 2M Sodium acetate 4 folds, 8M Urea 5 folds, 8M Urea 3 folds, 2M Sodium acetate 5 folds, 2M Sodium Benzoate 8 folds, 2M Ammonium Acetate and 2M Sodium Citrate 31 folds. Enhancement of solubility was more than 70% for levofloxacin in 2M Sodium Citrate. The enhancement of solubility of levofloxacin was due to the hydrotropic solubilization phenomenon. So 2M Sodium Citrate was used as hydrotrop for further method development and validation. Method was validated on different parameters like Linearity and Calibration curve was found y = 0.050x + 0.016 (R2= 0.998) for Levofloxacin. Response ratio was found about 0.0509 and response ratio curve was also prepared. LOD (0.3462) and LOQ (0.6892) were found. Accuracy in terms of % Recovery was found 99.6 for Levofloxacin. Precision in terms of mean % repeatability was 98.98 %, Intra-day precision was 99.417 and Inter-day precision was 99.1% and Analyst to Analyst precision was found 99.81%. All validation parameter are under limits that suggested by ICH guideline. Marketed formulation Levoflox-500 (tablet) was used to estimate Levofloxacin by UV- spectrophotometer. Assay result data was excellent 99.2% drug was estimated with 0.125 standard deviation and 0.132 % RSD.

Keywords: UV-Spectrophotometer, method development, validation, levofloxacin, hydrotropy.