STABILITY INDICATING ANALYTICAL METHOD VALIDATION FOR SIMULTANEOUS ESTIMATION OF FENTICONAZOLE NITRATE, TINIDAZOLE AND LIDOCAINE BY REVERSED PHASE-HPLCAbstract
The current study aims to develop a reversed-phase HPLC method for quantifying the active substances of Fenticonazole Nitrate (FENTI), Tinidazole (TINI) and Lidocaine base (LIDO) simultaneously and to validate the proposed method for the intended analytical application in the bulk and pharmaceutical dosage form by ICH guidelines. In this work, the behaviour of f FENTI, TINI and LIDO was studied under various degradative conditions, and a stability-indicating LC method was developed to separate the degradation products and quantify the drug in their presence. The mobile phase Phosphate buffering agent: Methanol: Acetonitrile (60:30:10; v: v: v), Hypersil Phenyl type silica column, with flow rate 1.0ml, detection wavelength 210nm, column temperature at 40ºC and Methanolis used as diluents. System Suitability, Specificity, Precision, Linearity, Accuracy, and Robustness parameters were all validated. The system suitability parameters were investigated by injecting the standard six times, and the results were well below the acceptance threshold. Linearity parameter was investigated at levels ranging from 80% to 120%, with a r2 value of 0.999 discovered. The formulation was tested using the above method and 102 % Fenticonazole Nitrate, 102% Tinidazole and 101% Lidocaine were found. So, this method can be used for routine analysis to estimate Fenticonazole Nitrate, Tinidazole, and Lidocaine in Pharmaceutical dosage form.
Gülay Yelken Demirel, Hande Çelebi Yatkın * and Burcu Engin
Exeltis Türkiye, Gazi Osman PaşaOsb. Fatih Bulvari No: 19/2 Çerkezköy/Tekirdağ.
06 August 2022
30 September 2022
23 October 2022
01 April 2023