ISSN : 2663-2187

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR QUANTIFICATION OF FLUCONAZOLE IN FLUCONAZOLE TABLET BY SPECTROSCOPY METHOD

Main Article Content

Bhaskar O. Aher, Khushali S. Deshmukh, Parag A. Pathade, Vinod A. Bairagi
» doi: 10.48047/AFJBS.6.14.2024.573-590

Abstract

For the purpose of quantifying fluconazole in pharmaceutical solid dosage forms such as capsules, uncoated, and dispersible tablets, an RPHPLC and a UV spectrophotometric assay method were designed and validated. A column was used to do the chromatography. This is a 5μm column with dimensions of 250 mm by 4.6 mm i.d. with a mobile phase of methanol: water (60:40 v/v) at a detector wavelength of 260 nm. It is 40°C in the Column Oven. Using 0.1 M HCl as the solvent, the UV technique was run at 260 nm. For HPLC and UV techniques, the linearity was measured at five different levels, ranging from 50 to 200 μg/ml and 50% to 150% of the test concentration, respectively. With a recovery of 98 to 102%, the HPLC technique proved to be exact and accurate for all dose forms examined. Relative Standard Deviation shouldn't be allowed to get above 2.0%. For the measurement of fluconazole only in tablet dosage form, the UV technique correlated well with HPLC. A broad-spectrum antifungal derived from synthetic triazole, it is effective against a variety of topical and systemic fungal infections orally and orally. It is recommended to treat and prevent the spread of oropharyngeal, oesophageal, or vulvovaginal candidiasis and deep visceral candidiasis. Fluconazole is an extremely picky C-14 sterol suppressor of fungal (Xdemethylated) cytochrome P450. According to the ICH, the developed technique was approved for specificity, linearity, precision, accuracy, reliability, limit of detection, and limit of quantification.

Article Details