Development and validation of stability indicating RP-HPLC method for the determination of related substances in Raloxifene hydrochloride tablets dosage forms

  • Babu C Department of Chemistry, Jawaharlal Nehru Technological University Anantapur, Anantapuramu, Andhra pradesh, India
  • Suresh Reddy K.V.N Department of Chemistry, GITAM Deemed to be University, Visakapatnam-530045, Andhra pradesh, India
  • Shashi Kumar K.N Department of H&S, Annamacharya Institute of Technology & Sciences, Kadapa-516003, Andhra pradesh, India

Abstract

This work is intended to thrive a stability-indicating high performance liquid chromatographic method for the analysis of Raloxifene HCl related compounds in pharmaceutical dosage forms. The separation was achieved Inertsil C8 (150 x 4.6 mm ID, 3.5μm)column using a gradient method. Mobile phase A is 0.01M KH2PO4 buffer (pH4.5), and mobile phase B is acetonitrile used in this work. 1.0 mL/ minute is the flow of rate and at 280nm noticed wavelength is monitored. For specificity, the limit of quantification, the limit of detection, linearity, accuracy, method precision, intermediate precision, robustness and stability this method is validated. The six injection impurities of standard solutions at the 4.0 µg/mL conjecture concentration were confirmed experimentally for LOQ values. The correlation coefficient of the impurities is more than 0.99. All impurities meet the criteria for linearity of both the impurities and raloxifene. The RSD recoveries obtained for impurities are not more than 10%. The achievement of this study demonstrated that the method is selective, linear, precise, rugged, robust and stability-indicating for the determination of related substances in raloxifene HCl tablet dosage form.

Keywords: Raloxifene hydrochloride, RP-HPLC, Method Validation, Degradation products, Stability indicating method

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Published
2019-10-16
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How to Cite
Babu C, Suresh Reddy K.V.N, & Shashi Kumar K.N. (2019). Development and validation of stability indicating RP-HPLC method for the determination of related substances in Raloxifene hydrochloride tablets dosage forms. International Journal of Research in Pharmaceutical Sciences, 10(4), 3325-3331. https://doi.org/10.26452/ijrps.v10i4.1641
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Original Articles
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