Stability-indicating HPTLC method for simultaneous determination of Ketoprofen, Methyl Paraben and Propyl Paraben in gel formulation

Abstract

Aim

A novel and quick HPTLC-densitometric method was developed for the simultaneous determination of Ketoprofen, Methyl Paraben, and Propyl Paraben.

Methods

Chromatographic separation of the drugs was performed on precoated silica gel 60 F₂₅₄ Merck plates using Toluene:Ethyl acetate:Glacial acetic acid (6.5:2.5:1.0 v/v/v) as a mobile phase. A TLC scanner set at 265 nm was used of Ketoprofen, Methyl Paraben, Propyl Paraben respectively were validated according to ICH guidelines. Forced degradation conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A (R2).

Results

The three drugs were satisfactorily resolved with R_f values of 0.33 ± 0.05, 0.54 ± 0.05, 0.71 ± 0.05 for Ketoprofen, Methyl Paraben, Propyl Paraben respectively. Calibration curves were polynomial in the range 200–1000 ng/band, 200–1500 ng/band, 100–600 ng/band, for Ketoprofen, Methyl Paraben, and Propyl Paraben respectively. Correlation coefficient (r) values were 0.9917, 0.9927, 0.9906 Ketoprofen, Methyl Paraben, Propyl Paraben respectively. The percentage recovery ranges from 99 to 101%.

Conclusion

A low relative standard deviation (<2%) was found for both precision and robustness study showing that the proposed method was precise and robust. The method had an accuracy of 99.95%, 99.85% and 100.07 of Ketoprofen, Methyl Paraben, Propyl Paraben respectively were validated according to ICH guidelines. The drug showed instability in oxide, heat and UV light, while it remained stable in neutral conditions.