QBD-based stability indicating liquid chromatography (RP-HPLC) method for the determination of Flurbiprofen in Cataplasm.

A non-steroidal drug called Flurbiprofen (FBN) has analgesic, anti-inflammatory, and antipyretic activity. In the current study, the determination of FBN in cataplasms does not have any pharmacopeial method. However, the drug substance, tablet, and ophthalmic solution formulations had pharmacopeial methods. The development and validation of an accurate, precise, and stability-indicating analytical method for the determination of FBN in cataplasmformulations. The gradient method was employed for the quantification of FBN in the presence of internal standards such as biphenyl. A nonpolar separation phase (C18), (250 x 4.6) mm, 5 μm Inertsil column (Make: GL Sciences) was used. The optimal flow rate, column oven temperature, injection volume, and detector wavelengths were 1.0 mLmin -1 , 40 °C, 20 μL,and 245 nm, respectively. Mobile phase A isa mixture of water and glacial acetic acid (GAA) (30:1 v/v) pH adjusted to 2.20 with GAA or 1 N NaOH; mobile phase B is Methanol (100 %); and the gradient elution program is time (min)/% B:5/60, 20/70, 25/70, 30/60,& 40/60.The obtained % RSD from the precision and intermediate precision was 0.7 % and 0.5 %. The % recovery ranged from 99.2 % to 100.4 %. The linear regression coefficient > 0.9996 indicates that all peak responses are linear with the concentration. The sample and standard solutions arestable for up to24 h on benchtop and refrigerator conditions. The critical peaks were well separated from the generated peaks due to forced degradation, including diluent and placebo peaks. The method validation data and QbD-based robustness study results indicate that the developed method is robust and fit for routine use in the quality control laboratory. The proposed method is specific, accurate,and precise, and QbD utilized the first-ever method for the determination of FBN in cataplasm formulations. Transdermal patches and gels have low extraction capacity this method isapplicable for quantification.