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

Authors

  • 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

DOI:

https://doi.org/10.14805/jphchem.2019.art112

Keywords:

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

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.

Author Biographies

Ananda Thangadurai Subramaniam, JKK Nataraja College of Pharmacy

Department of Pharmaceutical Analysis

Professor

Devi Velmurugan, Erode College of Pharmacy and Research Institute

Department of Pharmaceutical Analysis

PG Scholar

Sambathkumar Ramanathan, JKK Nataraja College of Pharmacy

Department of Pharmaceutical Analysis

Professor

Kamalakannan Dhanabalan, JKK Nataraja College of Pharmacy

Department of Pharmaceutical Analysis

Professor

Jambulingam Munusamy, The Erode College of Pharmacy and Research Institute

Department of Pharmaceutical Analysis

Hemanth Gampala, Swamy Vivekanandha College of Pharmacy

Department of Pharmaceutical Analysis

PG Scholar

References

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Published

2019-12-17