Development and validation of stability indicating RP-HPLC method for voriconazole

Abstract

This study describes the development and validation of stability indicating HPLC method for voriconazole, an antifungal drug. Voriconazole was subjected to stress degradation under different conditions recommended by International Conference on Harmonization. The sample so generated was used to develop a stability-indicating high performance liquid chromatographic method for voriconazole. The peak for voriconazole was well resolved from peaks of degradation products, using a Hypersil C18 (250×4.6 mm) column and a mobile phase comprising of acetonitrile: water (40:60, v/v), at flow rate of 1 ml/min. Detection was carried out using photodiode array detector. A linear response (r > 0.99) was observed in the range of 5-25 μg/ml. The method showed good recoveries (average 100.06%) and relative standard deviation for intra and inter-day were ≤ 1.5 %. The method was validated for specificity and robustness also.

Quantification of Anticoagulants Dabigatran, Rivaroxaban, and Prasugrel by Chromatographic and Spectrometric Techniques – Review

“…The run time was maintained for 5 min and the detection was monitored at 210 nm. Damle and Bagwe [22] developed and validated a simple, selective, and rapid stability indicating RP-HPLC method for the estimation of dabigatran etexilate analyte and it was resolved on a Neosphere C8 (150 mm×4.6 mm) column. The mobile phase consisted of methanol: phosphate Buffer (0.01 M pH 3) in the ratio of 60:40 v/v and sonicated to degas.…”

Development and Validation of RP-HPLC Method for the Estimation of Voriconazole in Bulk and Pharmaceutical Dosage Form

“…RP-HPLC method for determination of voriconazole in bulk and cream formulation was reported by Manali W. Jain et al 7 . Development and validation of stability indicating RP-HPLC method for voriconazole was studied by Khetre et al 8 . A validated LC method for separation and quantification of voriconazole and its enantiomer is also available in the literature 9 .…”

Development and Validation of Microbiological Analytical Method for Determination of Potency of Voriconazole Tablets

“…Voriconazole determination in pharmaceutical formulation by bioassay are scarce, where the majority of papers are related to its study include voriconazole determination in agar plate using sacharomyces cerevisiae 4 and voriconazole in plasma levels. 5,6 The most commonly described assay methods for voriconazole in tablets are UV Visible [7][8][9][10][11][12][13] and high performance liquid chromatography (HPLC) [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] may be also quantified by bioassay for its activity assessment. The purpose of this study was to develop and validate a microbiological analytical method to determine the potency of voriconazole in tablets.…”