Research Articles

Development and validation of RP-HPLC/UV methods for the estimation of Risedronate sodium in pure and pharmaceutical dosage form

Vol. 6 No. 1 (2019) Published December 17, 2019

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Abstract

Recent study was conducted to develop and validate analytical methods for estimation of Risedronate sodium in pure and pharmaceutical dosage form using UV Spectroscopy and               RP- HPLC method. The first method (Method A) based on the UV Spectroscopy using 0.1M Hcl as diluent lambda max was found at 261 nm. Linearity existed perceived in the concentration between 10-50 μg/ml (r 2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The second method (Method B), based on determination of Risedronate sodium tablet dosage form by RP-HPLC method.  Chromatography separation was carried out on a C18 (150X4.6 mm x5 µ) SS Column using Methanol: Ammonium formate (85:15) as the mobile phase at a flow rate of   1.0 ml/min. The chromatographic analysis was carried out in the reflectance and absorbance mode at 254 nm and retention time of the drug was found to be 1.11 ml/min for standard and tablet. Linear responses of the drug were in the concentration range of 200-1000 µg/ml. The accuracy of the method was assessed by standard dilution method and found to be 98% to              102% .The results of the analysis were validated statistically prism software. The method established was found to be simple, precise, linear, accurate and sensitive. The developed method can be used for routine quality control analysis of Risedronate sodium in pure and pharmaceutical dosage form.

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Author information

  • Ananda Thangadurai Subramaniam

    JKK Nataraja College of Pharmacy

  • Devi Velmurugan

    Erode College of Pharmacy and Research Institute

  • Sambathkumar Ramanathan

    JKK Nataraja College of Pharmacy

  • Kamalakannan Dhanabalan

    JKK Nataraja College of Pharmacy

  • Jambulingam Munusamy

    The Erode College of Pharmacy and Research Institute

  • Hemanth Gampala

    Swamy Vivekanandha College of Pharmacy

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Subramaniam, A. T.; Velmurugan, D.; Ramanathan, S.; Dhanabalan, K.; Munusamy, J.; Gampala, H. Development and Validation of RP-HPLC UV Methods for the Estimation of Risedronate Sodium in Pure and Pharmaceutical Dosage Form. J Pharm Chem 2019, 6 (1). https://doi.org/10.14805/jphchem.2019.art112.
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Received
November 16, 2019
Published
December 17, 2019
Section
Research Articles

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Keywords

  • Risedronate sodium
  • RP-HPLC
  • Validation
  • ICH guidelines
  • UV Spectrophotometry

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