Research Article
Definition of System Suitability Test Limits on the Basis of Robustness Test Results
Prafulla Kumar Sahu*Department of Pharmaceutical Analysis and Quality Assurance, Raghu College of Pharmacy, Dakamarri, Bheemunipatnam, Visakhapatnam-531 162, Andhra Pradesh, India
- *Corresponding Author:
- Prafulla Kumar Sahu
Department of Pharmaceutical Analysis and Quality Assurance
Raghu College of Pharmacy, Dakamarri
Bheemunipatnam, Visakhapatnam-531 162
Andhra Pradesh, India
Tel: +918121139575
E-mail: kunasahu1@rediffmail.com
Received date: April 19, 2017; Accepted date: May 05, 2017; Published date: May 15, 2017
Citation: Sahu PK (2017) Definition of System Suitability Test Limits on the Basis of Robustness Test Results. J Anal Bioanal Tech 8:363. doi: 10.4172/2155-9872.1000363
Copyright: © 2017 Sahu PK. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
A chromatographic method newly optimized to identify and assay four antihypertensive drugs in tablet dosage forms was complemented by a robustness test. The best system suitability criteria for numerous responses were evaluated on the basis of the robustness test results. Generally speaking, it is difficult to achieve a total satisfactory solution. Situations may also become ambiguous if the system suitability limits for few responses of a robust method are violated. In this context, it becomes crucial to redefine these limits based on the robustness test results. In the present study, the extreme experimental (worst-case) conditions that offer worst result but still acceptable and likely to occur were predicted from the robustness test effects. Eventually, replicated experiments were executed in such worst conditions and the system suitability test (SST) limits were determined.
