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Abstract
In the present work, a new reverse phase–high performance liquid chromatography (RP–HPLC) method was developed, validated, and compared for estimation of the bis-triazole antifungal fluconazole (FLZ), in different simulated biological fluids, that is, gastric fluid simulant (GFS, pH = 1.5), vaginal fluid simulant (VFS, pH = 4.2), topical simulated media-phosphate buffer (PB, pH = 6.8), blood plasma simulant-phosphate buffer saline (PBS, pH = 7.4) and in methanol. For RP–HPLC the chromatography was carried out on a octadecyl silane (ODS-3) Hypersil C18 column (250 mm × 4.6 mm × 5 µm) using water (pH 5.2, adjusted with orthophosphoric acid) and acetonitrile (80:20, v/v) as the mobile phase at a flow rate of 2.5 mL/min with detection at 260 nm. The calibration curve of standard FLZ was linear in the range 0.2–40 µg/mL, 0.1–40 µg/L, 0.2–40 µg/mL, 0.1–40 µg/mL, and 0.2–50 µg/mL, in GFS, VFS, PB, PBS, and in methanol, respectively. All the methods were validated with respect to linearity, precision, accuracy, and specificity for intra- and inter-day and satisfied the International Conference on Harmonisation (ICH) and United States Food and Drug Administration (USFDA'S) guidelines.
ACKNOWLEDGMENT
The authors are grateful to the authorities of Delhi College of Pharmacy (DIPSAR), New Delhi, India, and the R.V. Northland Institute, Uttar Pradesh, India, for providing the necessary facilities to carry out the research work. The authors are also grateful to Ranbaxy, Gurgaon and Mankind Pharmaceutical Ltd, New Delhi, India, for supplying reference and standard fluconazole, respectively, as a kind gift to carry out this work. Authors are also grateful to Dr. Nita Mondal for her valuable suggestions during preparation of manuscript.
Notes
Media 1, Gastric fluid simulant (GFS); Media 2, Vaginal fluid simulant (VFS); Media 3, Phosphate buffer (PB); Media 4, Phosphate buffer saline (PBS); Media 5, Methanol.
Media 1, Gastric fluid simulant (GFS); Media 2, Vaginal fluid simulant (VFS); Media 3, Phosphate buffer (PB); Media 4, Phosphate buffer saline (PBS); Media 5, Methanol.
Media 1, Gastric fluid simulant (GFS); Media 2, Vaginal fluid simulant (VFS); Media 3, Phosphate buffer (PB); Media 4, Phosphate buffer saline (PBS); Media 5, Methanol.
Mean value represent three (n = 3) different standard samples for each concentration (µg/mL). Inter-day reproducibility was determined from three different runs for each concentration over 72 hr.
Media 1, Gastric fluid simulant (GFS); Media 2, Vaginal fluid simulant (VFS); Media 3, Phosphate buffer (PB); Media 4, Phosphate buffer saline (PBS); Media 5, Methanol.
a Average of three (n = 3) determinates, Product 1: Fluzol-150, Product 2: Nuforce-150, Product 3: Fungid-150.
Media 1, Gastric fluid simulant (GFS); Media 2, Vaginal fluid simulant (VFS); Media 3, Phosphate buffer (PB); Media 4, Phosphate buffer saline (PBS); Media 5, Methanol.
a Average of six (6) independent determinations.
Media 1, Gastric fluid simulant (GFS); Media 2, Vaginal fluid simulant (VFS); Media 3, Phosphate Buffer (PB); Media 4, Phosphate buffer saline (PBS); Media 5, Methanol.