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Reversed-phase Ultra-Performance Liquid Chromatographic Method for Development , Validation and Determination of Impurities Related to Valsartan anti hypertensive drug.
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| Author:
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BHAVANI VUKKUM, T.SIVA RAO, JAMEELA BEGUM
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| Abstract:
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A simple, rapid and more accurate stability indicating RP-UPLC method was developed and validated for the estimation of Valsartan related impurities in tablets formulation. The developed method is found to be specific, reproducible and stability indicating. Aquity UPLC-BEH C-18 column (100 X 2.1 mm, 1.7 µm) column was used and mobile phase consisted of 0.1% ortho phosphoric acid in water and in Acetonitrile with gradient programme to achieve good resolution and retention of the analyte and its impurities .The detection was performed at 254nm.From the linearity study slope values of imp-A, imp-B, imp-C, imp-D, and imp-E were established. The molecule is forced to all stress conditions such as acid, base, oxidation, heat, photolysis, UV-light and humidity as per the recommendation of ICH guidelines. All degradants are well separated from the main analyte. The method is proved to be robust to change in column temperature and flow rate. The proposed method is found to be sensitive, precise, rapid, reproducible, good limit of detection (LOD) and limit of quantification (LOQ) and offers good column life time.
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| Keyword:
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UPLC; Valsartan; Forced degradation; Validation; Stability-indicating, Mass spectroscopy
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| EOI:
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| DOI:
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