Designed Reverse Phase HPLC Method for Validation for determination of API Nifedipine in the Nifedipine 20 mg Tablet Formulation

Abstract

A novel, safe and sensitive method of Designed Reverse phase HPLC method for validation for determination of API Nifedipine in the Nifedipine 20 mg tablet formulation. It has been developed for the assay of Nifedipine in its tablet formulation. The method have been developed and validated for the assay of Nifedipine using acetonitrile. Which does not shows any interference in Reverse phase HPLC estimations. All the parameters of the analysis were chosen according to ICH [Q2 (R1)] guideline and validated statistically using RSD and %RSD along with neat Spectrogram. The percentage recoveries for ranged from 99.97-100.0%, respectively. The method was found to be robust and can be successfully used to determine the drug content of marketed formulations. The method gives resolution with a short analysis time. The method parameter was validated and establishes to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. Therefore, the planned method can be used for routine analysis of in medical dosage form.