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Mohd Sayeed Shaikh, Mayura A. Kale, P. R. Mahaparle, Hrishikesh Rajput, Somnath M. Karkhele
1Department of Pharmaceutical chemistry, Government College of Pharmacy, Osmanpura, Aurangabad-431 005, Maharashtra, India.
2Department of Pharmaceutical Chemistry, Shreeyash Institute of Pharmaceutical Education and Research, Aurangabad, Maharashtra, India.https://doi.org/10.33786/JCPR.2020.v10i03.004
A UV spectrophotometric method was developed and validated for the determination of luliconazole (LZL) in bulk and cream formulation using a solvent composed of methanol: water (80:20) at a pre-determined λmax of 298 nm, it was demonstrated linear in the range of 1.0–10.0 μg/mL, and exhibited good correlation coefficient (r2=0.999) and excellent mean recovery (99.03–100.40 %). This method was successfully applied to the determination of LZL content in five marketed brands with recovery range (97.70–99.60 %) and the promising results obtained according to the label claims. The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The method is also adopted for measurement of equilibrium solubility as per WHO guideline in different organic solvents and water. Method was also utilized for stability of analytical solution or short-term stability at room temperature (TRT) and cold temperature (TCT)upto 72 hours as a part of robustness as per ICH Q2R1.Similarity Factor (Sf) and System Suitability Testing were found to be 1 &2.0 % respectively.
Luliconazole, UV estimation, equilibrium solubility, stability of analytical solution, sf\Similarity Factor, System Suitability Testing.
CONFLICT OF INTEREST
The authors declare that they have no conflict of interest.
Received: 17 December 2019
Accepted: 16 February 2020