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Validation of Fluvastatin Sodium by HPLC Method Venkatesh D.P.*, Karki Roopa, Andhale Ganesh S., Goli Divakar Department of Pharmaceutics, Acharya and BM Reddy College of Pharmacy, Bengaluru, India *Email: venkateshdp@acharya.ac.in
Online published on 27 September, 2019. Abstract The HPLC method was developed for Fluvastatin Sodium for the pure drug. The determination was performed on LC, column part no: 00G-4252-EQ, dimension: 250x4.6 mm, mobile phase containing Methanol & Acetonitrile: 1-Octane sulphonic acid at pH 2.5 (60: 40), with a flow rate 1ml/min and retention time was 3–4 min using UV detector with wave length 230 nm was used. The linearity of Fluvastatin sodium was found to be in the concentration range of 2–12 μg/ml with regression coefficient of 0.999 was observed. The percentage recovery data was found to be within 98–102% indicating that method is accurate. The LOD and LOQ were found to be 5.4 and 1.7 μg/ml respectively. The percentage recovery data was found to be within 98–102%. HPLC method for Fluvastatin sodium was validated as per ICH guidelines. Top Keywords Fluvastatin sodium, Validation, HPLC, ICH guidelines. Top | |
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