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P. 52
Ph.D.
(Pharmacy)
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR
THE DETERMINATION OF DRUGS USED IN THE TREATMENT OF
OPHTHALMIC DISEASES
Ph.D. Scholar : Baria Dharmendrasinh Aratsinh
Research Supervisor : Dr. Satish A Patel
Regi. No.: 16146021001
Abstract :
The present work is divided into major eight parts, which has started with introduction
about disease, drug profile and various analytical techniques like UV Spectroscopy and
Chemometric assisted methods, HPTLC and HPLC and literature review. Followed by
method development and validation using UV spectroscopy, HPTLC and HPLC
approache. Then the developed methods were analyzed statistically by ANOVA.
UV spectrophotometric approaches, particularly the first derivative method and
chemometric assisted spectroscopic methods, are being used along with Artificial Neural
Network (ANN) for the simultaneous determination of drugs used to treat eye disorders in
the current study. They've been found to be both cost-effective and sensitive, and
chemometric approaches have the added benefit of not requiring any prior separation. In
their combined pharmaceutical formulation, chromatographic techniques such as HPLC
and HPTLC were also developed and successfully employed to estimate Phenylephrine
hydrochloride, Naphazoline hydrochloride, Sulfacetamide sodium, Prednisolone acetate,
and Hydrocortisone acetate. The stability-indicating RP-HPLC method was also
developed and applied to estimate Sulfacetamide sodium and Prednisolone acetate in
artificial mixture.
The developed chromatographic methods (HPLC and HPTLC) were found to be more
sensitive than spectroscopic methods. A developed stability-indicating RPHPLC method
for Sulfacetamide sodium and Prednisolone acetate in synthetic mixtures can have the
ability to detect degradants of the drug components in the presence of additives in the
formulation. The developed HPTLC method uses the least amount of solvents as well as
stationary plates (TLC plates), so we can say it is the most economical method among all
the developed methods for the simultaneous estimation of drugs used to treat
ophthalmic diseases.
All the developed approaches were validated according to ICH Q2(R1) guidelines for the
parameters like linearity and range, precision, accuracy, limit of detection and
quantification and robustness.
The assay results of the all the developed methods were subjected to the comparison by
using statistical analysis tool. Here in this study ANOVA was used for the comparison of
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