Abstract

A STUDY OF ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IMPURITIES IN DICYCLOMINE HYDROCHLORIDE CAPSULE DOSAGE FORM BY RP-HPLC METHOD

Chitra Manickam, Gokulakannan Mohan*, Vijayamirtharaj Ramaswamy and Senthil Kumar Natesan

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Abstract

This study's objective was to Developed and validated a new Reverse Phase-High- Performance Liquid Chromatography (RP-HPLC) method for the determination of Impurities in Dicyclomine HCl capsules. The method was developed by adapting the USP API monograph and checked for feasibility study and applied to capsule formulation, In this API methods methods not suitable for estimation of impurities in capsule formulation, hence study was made in changing the column for Known impurity, diluent composition, pH of the mobile phase, Flow rate change and different mobile phases for unknown impurities. By trailed with above explained aspects developed new method for determination of impurities in capsule formulation. This method was developed with an emphasis on specific, linear, accurate and reproducible and compliant with International Council for Harmonization (ICH) guidelines for method validation. The obtained results of validation parameter within the Acceptance criteria. This implies high reliability of %impurities present in determination of Dicyclomine Hcl capsules with accuracy in method precision samples. In conclusion, the newly developed RP-HPLC methods provides an efficient and precise tool for estimation of impurities in capsule formulations. This facilitates accurate impurity content assessments in routine quality control tests for pharmaceutical companies. This study makes a significant contribution to the evolution of pharmaceutical analytical techniques, offering valuable insights into the use of validated RP-HPLC method.

Keywords: Dicyclomine Hcl RP-HPLC Method Development & Method Validation.