HPTLC METHOD DEVELOPMENT AND VALIDATION OF CINNARIZINE IN BULK AND MARKETED FORMULATIONAbstract
High performance thin layer chromatography (HPTLC) offers many advantages over HPLC. It reduces the cost of analysis as compared to HPLC. The mobile phase consumption per sample is extremely low in HPTLC, hence reducing the acquisition and disposal cost. Considering the cost and suitability of analysis for estimation of cinnarizine in bulk and its marketed formulation, HPTLC method was developed and validated. The Camag HPTLC system, employed with software win CATS (ver.126.96.36.199) was used for proposed analytical work. Planar chromatographic development was carried out with the help of Silica Gel 60 F254precoated TLC plates. Sample application was facilitated by Linomat 5 applicator. After sample application plates were subjected for ascending development in twin trough chamber of 10×10 cm dimension, using 10 ml of solvent system. The optimized mobile phase was composed of toluene: ethanol (7.5:2.5 v/v). In post development, the plates were air dried and then scanned densitometrically using a UV detector at 254 nm in absorbance mode. In HPTLC densitogram well defined peak was obtained for cinnarizine with starting position at 0.69 Rf, max position at 0.72 Rf and end position at 0.75 Rf. The optimal Rf value for cinnarizine was found to be 0.72. Performance characteristics of HPTLC method for estimation of cinnarizine in bulk and its marketed dosage form were statistically validated as per recommendations of ICH guidelines of analytical method validation. The HPTLC method was found to be linear across the range 50-400 ng/band. The LOD and LOQ values were found to be 0.05162 and 0.1564 ng/band respectively. The method was found to be accurate, precise, robust and economical for the analysis of cinnarizine from bulk and its formulation.
Abhay R. Shirode *, Aditya D. Ghuge and Vilasrao J. Kadam
Department of Quality Assurance, Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai, Maharashtra, India.
11 January, 2016
12 February, 2016
02 March, 2016
01 June 2016