Objective: The objective of the present work was to develop and validate the stability-indicating method for the simultaneous estimation of itraconazole and terbinafine HCl in bulk and pharmaceutical tablet dosage form by reversed-phase high-performance liquid chromatography (HPLC). This combination of drugs is not reported for simultaneous HPLC analysis as of now.
Methods: The analysis of the developed method was carried on Shimadzu LC Prominence-i 2030 model with Lab Solution software and the separation was done on Shim-pack C18 GIST (250 mm×50 mm, 5 μm) column with a flow rate of 1.2 ml/min and run time of 12 min. The injection volume was 10 μl and mobile phase consisted of acetonitrile and 0.1% triethylamine in the ratio of 90:10 and 225 nm was used as a detection wavelength.
Results: The retention time was found to be 3.464 min and 8.705 min for itraconazole and terbinafine HCl, respectively. The calibration curve was found to be linear and r2 values were 0.9989 and 0.9995 for itraconazole and terbinafine HCl, respectively.
Conclusion: The stability-indicating method was developed by subjecting itraconazole and terbinafine HCl marketed formulation to various stress conditions such as acidic, basic, oxidative, thermal, and water hydrolysis degradation conditions and the degraded product peaks were well resolved from sample peaks.
The objective of the study was to develop and validate a novel, stability
indicating, simple, rapid, accurate, precise and isocratic reverse-phase high-performance liquid
chromatographic (RP-HPLC) method for simultaneous estimation of benserazide HCl and
levodopa in a marketed formulation. Chromatographic separation was achieved by using C18
Cosmosil 4.6 × 250 mm column with a mixture of phosphate buffer pH 2 and acetonitrile in
proportion of 95:5 as mobile phase at a flow rate of 1.0 ml/min and column temperature 25°C.
The detection was carried out at 210 nm using UV detector. The retention time for benserazide
and levodopa was found to be 3.1 minutes and 6.6 minutes respectively and recoveries from
tablet were between 98 and 102 %.
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