Abstract

VALIDATION OF STABILITY INDICATING HPLC METHOD FOR THE ASSAY OF FELODIPINE (API)

Saloni S. Wagh, Dr. Seema Kothari and Dr. Manohar V. Lokhande*

Abstract

Three impurities were identified from Felodipine Active Pharmaceutical Ingredient (API). The method for analysis for felopdine is chosen high performance liquid chromatography (HPLC) and was validated according to ICH guidelines. The Retention time of standard solution is 12.952 mins and Retention time of sample solution is 13.028 mins. System precision of its the RSD is 0.05% Method precision the RSD is 0.30%. Overall RSD is 0.46% in Ruggedness. The test method is validated for Specificity, Precision and Ruggedness and found to be meeting the predetermined acceptance criteria. The validated method is Specific, Precise and Rugged for Assay of Felodipine API .Hence this method can be introduced into routine use for the assay of Felodipine API. The parameters such as HPLC, Specificity, Precision, Ruggedness, System Suitability and Linearity were analyzed.

Keywords: HPLC, Specificity, Precision, Ruggedness, System Suitability and Linearity.