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Abstract
In this thesis we have approached the new chromatographic
techniques like HPLC/UPLC which can improve the analysis throughput
and cycle times. The proficient research work has been divided in to five
chapters. The thesis is composed of four articles, two active
pharmaceutical ingredients, one combination drug product and one
key starting raw material which was selected for the research work.
Keeping in view, the objective to develop new analytical methods for
the determination of related components, assay and enantiomeric
purity.
Chapter-l: Introduction and importance of analytical method
development in pharmaceutical research and development
In this chapter a brief outline on importance of development of novel
liquid chromatographic methods for related components estimation in
pharmaceutical research and development, importance of impurity
evaluation and ICH methodology for stability indicating method
development were explained.
Chapter-2: A validated new chiral LC method for the enantiomeric
separation of vildagliptin
Vildagliptin is a new oral anti-diabetic drug of the dipeptidyl
peptidase-4 inhibitor class of drugs used as a single enantiomer (S).
Galvus is a brand name for Vildagliptin.
This chapter comprised chiral analytical method development and
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method validation of S-vildagliptin and its other enantiomer by HPLC.
Chapter-3: Simultaneous determination of Sitagliptin phosphate
monohydrate and Metformin hydrochloride in tablets by validated
ultra performance liquid Chromatography Method
Sitagliptin phosphate monohydrate and Metformin hydrochloride are
oral anti-diabetic drugs. Sitagliptin phosphate is used for the
improvement of glycemic control in patients with type II diabetes mellitus
as monotherapy or combination therapy with metformin when the single
agent does not provide adequate glycemic control. The brand name is
Janumet.
This chapter comprised analytical method development for the
simultaneous determination of sitagliptin phosphate monohydrate and
metformin hydrochloride in pharmaceutical dosage forms and its
analytical method validation by HPLC.
Chapter-4: A validated LC method for the determination of chiral
purity of (S)-2-azido-3-methylbutanoic acid: a key raw material of
Valganciclovir hydrochloride
(S)-2-azido-3-methylbutanoic acid is a single enantiomer and very
critical as it affects the overall chiral purity of Valganciclovir
hydrochloride. Valganciclovir hydrochloride is an antiviral drug. The
brand name is Valcyte.
This chapter comprised chiral analytical method development and
method validation of (S)-2-azido-3-methylbutanoic acid and its other
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enantiomer by HPLC.
Chapter-5: A stability indicating UPLC method for the rapid
separation of related components of Gemcitabine hydrochloride
Gemcitabine hydrochloride is a chemotherapeutic agent that works by
slowing or stopping the growth of cancer cells and marketed as Gemzar
by Eli Lilly and company.
This chapter comprised analytical method development for process
related impurities, degradation products in Gemcitabine API and its
analytical method validation by HPLC.