A simple RP-HPLC method for the simultaneous quantitation of chlorocresol, mometasone furoate, and fusidic acid in creams.
A simple, specific, and precise high-performance liquid chromatographic method is developed and validated for the simultaneous determination of chlorocresol (CC), mometasone furoate (MF), and fusidic acid (FA) in a cream formulation. The isocratic mobile phase consists of 1.5% w/v aqueous ammonium acetate buffer-acetonitrile, 55:45 (v/v) of pH 3.8. The column contains octylsilyl chemically bonded to porous silica particle (Symmetry C8, 150x3.9 mm, 5 microm). The detection is carried out using variable wavelength UV-vis detector set at 240 nm. The solutions are chromatographed at a steady flow rate of 1.0 mL/min. The current method separates CC, MF, and FA in less than 8 min with good resolution and peak shapes, minimal tailing, and with retention factors between approximately 1 and 5. Linearity range and percent recoveries for CC, MF, and FA are 10-30, 10-30, and 200-600 microg/mL; and 100.31%, 100.38%, and 100.34%, respectively. The method is validated according to International Conference on Harmonization guidelines and proven to be suitable for stability testing, content uniformity testing, and quality control of these compounds in pharmaceutical preparations.
Shaikh
Saleem
S
Department of Analytical Research and Development, Jamjoom Pharmaceuticals, P.O.Box- 6267, Jeddah-21442, Saudi Arabia.
Muneera
M S
MS
Thusleem
O A
OA
Tahir
Muhammad
M
Kondaguli
Anand V
AV
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003408:Cresols / Q000032:analysis*; D004304:Dosage Forms; D004340:Drug Contamination; D004355:Drug Stability; D005672:Fusidic Acid / Q000032:analysis*; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D003408:Cresols; D004304:Dosage Forms; D011244:Pregnadienediols; D000068656:Mometasone Furoate; C006984:chlorocresol; D005672:Fusidic Acid