Quality Analysis Methods
(1) Research Title:“Studies on Development of Analytical method, validation and applications for some formulated Drugs”
(2) Objectives:
The prime objectives of the proposed research work would be:
(a) To develop HPLC method for quality dimension &quantification of the drug substance with highest selectivity, precision and accuracy.
(b) Forced degradation study to confirm the stability of the drug substance.
(c) Perform analytical method validation for the proposed method as per ICH guideline.
(3)Introduction:
• Origin of the research problem
Pharmaceutical analytical chemistry is an important part in monitoring the quality of pharmaceutical products for safety and efficacy. With the advancement in synthetic organic chemistry and other branches of chemistry including bio-analytical sciences and biotechnology, the scope of analytical chemistry has enhanced too much higher levels. The emphasis in current use of analytical methods
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Quality control is a concept, which strives to produce a perfect product by series of measures designed to prevent and eliminate errors at different stage of production. The decision to release or reject a product is based on one or more type of control action. With the growth of pharmaceutical industry during last several years, there has been rapid progress in the field of pharmaceutical analysis involving complex instrumentation. Providing simple analytical procedure for complex formulation is a matter of most importance.
The most characteristic feature of the development in the methodology of pharmaceutical and biomedical analysis during the past 25 years is that HPLC became undoubtedly the most important analytical method for identification and quantification of drugs, either in their active pharmaceutical ingredient or in their formulations during the process of their discovery, development and manufacturing[6-12].
(4)
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