High performance thin-layer chromatographic selective and stability indicating method for assay of ciprofloxacin in pharmaceuticals
By Babita K Singh, Dilip V Parwate, Seema Srivastava and Sudhir K. Shukla
A sensitive, precise, selective and stability indicating high performance thin-layer chromatographic (HPTLC) method was developed and validated for the quantitative analysis of ciprofloxacin hydrochloride. The stationary phase employed was precoated silica gel 60F254 HPTLC aluminium sheets and the mobile phase consisted of dichloromethane: methanol: ammonia (30:60:10, v/v/v). Densitometric measurement was performed in reflectance/ absorbance mode at 279 nm. In the chromatogram, a sharp and well-defined symmetrical peak was obtained with Rf value of 0.62 ± 0.03. With the mobile phase employed in the study complete separation of ciprofloxacin from other structurally similar fluoroquinolones was elucidated; the degradation products of ciprofloxacin, formed under accelerated stress conditions, are also well resolved. The linear regression analysis was deduced to be suitable for the calibration data in the concentration range 100-600ng spot-1. The high throughput HPTLC method is convenient and precise for the quantitative analysis of ciprofloxacin hydrochloride in bulk drugs, tablets and counterfeit samples.
Key words: Ciprofloxacin, HPTLC, stability indicating, selective, validation.