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Presented work is a typical representation of an assay analytical method validation as per ICH guidelines using two simple instrumentations- UV Spectrophotometer and HPTLC. Various validation parameters like specificity, precision, accuracy, linearity, robustness and ruggedness of the analytical methods are elaborated with reliable statistical treatments. This complete work was carried out in laboratory premises of Delhi University as per of M. Pharmacy project and had been examined by experts prior to final submission for grant of M. Pharm degree. Moxifloxacin Hydrochloride, a broad spectrum…mehr

Produktbeschreibung
Presented work is a typical representation of an assay analytical method validation as per ICH guidelines using two simple instrumentations- UV Spectrophotometer and HPTLC. Various validation parameters like specificity, precision, accuracy, linearity, robustness and ruggedness of the analytical methods are elaborated with reliable statistical treatments. This complete work was carried out in laboratory premises of Delhi University as per of M. Pharmacy project and had been examined by experts prior to final submission for grant of M. Pharm degree. Moxifloxacin Hydrochloride, a broad spectrum flouroquinolone antibiotic was the analyte of this work and assay methods were developed and validated for both the active pharmaceutical ingredients and ophthalmic solutions. This research activity was carried out in academic facility and had some specific limitations that needed further explorations. Therefore, any suggestions and gentle opinions will be warmly welcomed.
Autorenporträt
Vandana Dhillon, M.Pharm, Delhi University.