Abstrakt

ICH Guidelines in Practice: Development and Validation of HPTLC Method for Simultaneous Estimation of Ketorolac Tromethamine and Ofloxacin in Ophthalmic Formulation.

Vrushali Tambe, Manaswi Patil, Ujjwala Kandekar, and Shrivastava SK

Ketorolac Tromethamine (KET) and Ofloxacin (OFL) from bulk and eye drop formulation were precisely and accurately determined using developed high performance thin layer chromatographic (HPTLC) method. Analysis was done on silica gel 60F254 as stationary phase with aluminum backed TLC plates. Dichloromethane: Methanol: Ammonia 25% (6:3:1) was used as a mobile phase. The two drugs were satisfactorily resolved with Rf 0.79± 0.03 and 0.41± 0.02 for KET and OFL respectively. The method performance was validated as per ICH guidelines. Linearity was found in the range of 25-75ng/band (r2 = 0.999) for KET and 15- 45ng/band (r2 = 0.9998) for OFL. The assay results were found to be 99.14±0.413 %w/w and 98.11±0.232 % w/w for KET and OFL respectively. The % Recovery for KET was in the range of 99.74-99.95% w/w and that of OFL was 99.78-99.87% w/w. This validated method can be used for simultaneous estimation of KET and OFL from bulk and ophthalmic formulation.