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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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