METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE

  • Shalini Bhardwaj
  • M. K. Gupta
  • V. Bhalla

Abstract

A simple and rapid stability indicating, ultra performance liquid chromatographic (UPLC) method was developed and validated for the determination of Nifedipine. The quantitative determination of Nifedipine drug was performed on a Sunniest C-18-HT, 2m, (50 2.1nm) column with gradient elution. For UPLC method, UV detection was made at 335nm. During method validation, parameters such as precision, linearity, stability, robustness and specificity were evaluated, which remained within acceptable limits. Forced degradation studies of Nifedipine were studied under acidic and alkaline stress conditions. Mild degradation of the drug substance was observed during acidic hydrolysis and no degradation was observed during basic hydrolysis.

Keywords: Nifedipine, UPLC, Stability indicating assay, Validation.

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How to Cite
Bhardwaj, S., M. K. Gupta, and V. Bhalla. “METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 4, Feb. 2018, pp. 24-42, doi:10.22270/ijdra.v3i4.174.