Applying green analytical chemistry (GAC) for development of stability indicating HPLC method for determining clonazepam and its related substances in pharmaceutical formulations and calculating uncertainty

Loại tài liệu:

Article

Tác giả:

Eldin, A.B.

Đề mục:

Arabian Journal of Chemistry

Nhà xuất bản:

Elsevier Ltd.

Ngày xuất bản:

November 2019

Định dạng:

pdf

Nguồn gốc:

Arabian Journal of Chemistry, Volume 12, Issue 7 , November 2019, Pages 1212-1218

Ngôn ngữ:

eng

Lượt xem:

Lượt tải:

Nội dung

Clonazepam contains one benzodiazepine ring in its chemical structure which makes it vulnerable to degradation. In this study, green analytical chemistry approach was applied in attempts for the development of validated stability indicating RP-HPLC method for determining clonazepam and its related substances in pharmaceutical formulation. Validation has been performed according to ICH guidelines. Assay was capable of simultaneous monitoring of the intact drug in the presence of its related substances within the same run. HPLC assay involved an ODS column and a mobile phase composed of 2% sodium dodecyl sulfate, 0.05 M sodium acetate buffer pH 3.5 and isopropanol in ratio (25:55:20) at a flow rate of 1.5 mL/min and detection was carried out at 254 nm. HPLC method allowed good resolution between the peaks that corresponded to the active pharmaceutical ingredients and its degradation products with good linearity, precision, accuracy, specificity, LOD and LOQ. The expanded uncertainty (0.33%) of the method was also estimated from method validation data. This analytical technique is not only ecofriendly but also faster than the conventional liquid chromatographic system official in the USP-36.

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Applying green analytical chemistry (GAC) for development of stability indicating HPLC method for determining clonazepam and its related substances in pharmaceutical formulations and calculating uncertainty

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