Asian Journal of Pharmacy and Technology

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Review on Development of Analytical Method and Validation by Reverse Phase – High Performance Liquid Chromatography


Affiliations
1 Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, India
2 Department of Pharmaceutics, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, India
     

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RP-HPLC is the most, sensitive, universal analytical procedure. It is extremely versatile tech where analytes are separated by passes through column of different sized particles. Analytical method development ensures the specific characteristics of the drug substances against the preconceived acceptance criteria, while method meets objectives required at each stage of development of drug which is a continuous process, and should be robust and accessible. Validation of analytical method demonstrates the scientific firmness of measurement or characterization and is required throughout the regulatory submission process and the main purpose of validation of API is to demonstrate that it maintains the desired level of compliance and also suitable for its intended purpose.

Keywords

RP-HPLC, Validation, Column, Analytical, Flow Rate, Mobile Phase
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  • Review on Development of Analytical Method and Validation by Reverse Phase – High Performance Liquid Chromatography

Abstract Views: 131  |  PDF Views: 0

Authors

H. S. Jumde
Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, India
S. D. Mankar
Department of Pharmaceutics, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, India

Abstract


RP-HPLC is the most, sensitive, universal analytical procedure. It is extremely versatile tech where analytes are separated by passes through column of different sized particles. Analytical method development ensures the specific characteristics of the drug substances against the preconceived acceptance criteria, while method meets objectives required at each stage of development of drug which is a continuous process, and should be robust and accessible. Validation of analytical method demonstrates the scientific firmness of measurement or characterization and is required throughout the regulatory submission process and the main purpose of validation of API is to demonstrate that it maintains the desired level of compliance and also suitable for its intended purpose.

Keywords


RP-HPLC, Validation, Column, Analytical, Flow Rate, Mobile Phase

References