HPTLC Method Development and Validation: Strategy to Minimize Methodological Failures
PATEL RASHMIN1*, PATEL MRUNALI2, DUBEY NITIN3, DUBEY NIDHI4 AND PATEL BHARAT5
1. A. R. College of pharmacy & G. H. Patel Institute of Pharmacy, Vallabh Vidyanagar – 388120. Anand, Gujarat, India
2. IndukakaIpcowlalaCollege of Pharmacy, New Vallabh Vidyanagar – 388121. Anand, Gujarat, India
3. College of Pharmacy, IPSAcademy, Indore, Madhya Pradesh, India
4. School of Pharmacy, DeviAhilyaUniversity, Indore, Madhya Pradesh, India
5. CharotarUniversity of Science & Technology (CHARUSAT), Changa, Anand, Gujarat, India
(Received: May 7, 2012; Accepted: October 17, 2012)
ABSTRACT
This paper provides information regarding HPTLC-based analytical method development and evaluation of validation characteristics in accordance with best practice. As a result it meets standards comparable with other chromatographic techniques with specific aim to minimize confusion and methodological failure. The poor performance to the method development may be caused by systematic and scientific approach for the selection of separation mode, stationary phase and mobile phase not taken into consideration. The poor validation practice may be caused by validation guidelines which are not fully understood or partially neglected, steps of the analytical procedure are not fully considered during validation or specification limits defining validation characteristics are not described.
Key words: HPTLC, Method development, Method validation