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  • Title: Development & validation of reversed phase HPLC method for quantification of water insoluble API.
    Author: Yasmin R, Shoaib MH, Muhammad IN, Bashir L, Naz S, Ali H, Zafar F, Siddiqui F.
    Journal: Pak J Pharm Sci; 2017 Sep; 30(5(Supplementary)):2021-2024. PubMed ID: 29105638.
    Abstract:
    In the present work a specific, accurate, precise, and reproducible UV-HPLC method was developed and validated for the analysis of Aceclofenac. This method involved elution of Aceclofenac in a mobile phase which is composed of buffer pH 6.8 (i.e. using 0.01N KH2PO4) and HPLC grade Acetonitrile (60:40). Separation of the analyte was achieved using HPLC isocratic pump attached to the UV-VIS detectorC18, guard column and C18 column. The injection volume was 20μL, detected at 274 nm; flow rate: 1mL/min. Standard calibration curve was measured and found linear from 0.1 to 40μg/ml. The validation parameters were measured according to FDA guidelines and successful results were obtained. The presented analytical method could be employed for pharmacokinetic studies.
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