Stability Indicating Assay For Mirtazapine As Per ICH By UPLC & HPL.

      Аннотация: UPLC - Ultra performance Liquid Chromatography, is highly sophisticated advanced instrument introduced in the Pharma Industries. Here we have covered the advancements that have been made in this instrument by giving more stress on its columns. It comprises of five types of columns each designed for specific samples. This book also covers the specification of the columns, along with their instrumentation. Stability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this article. Stability testing Provide a evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. To establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Because physical, chemical or microbiological changes might impact the efficiency and security of the final product.

Ключевые слова: HPLC, ICH, UPLC, MIRTAZAPINE