Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques

Extract:
Chapter 1, INTRODUCTION:
Introduction to analytical chemistry (1-4):
Analytical chemistry may be defined as the science and art of determining the composition of materials in terms of the elements or compounds contained . Large number of drug/s introduced in the pharmaceutical market is increasing per year. These drugs may be either new entities or partial structural modification/s of the existing one. Very often there is a time delay from the date of introduction of a drug in the market to the date of its inclusion in pharmacopoeias. This is because of the possible uncertainties in the continuous and wider usage of these drug/s, reports of new toxicities (resulting in their withdrawal from the market), development and introduction of better drug/s by competitor/s. Under these conditions, standard/s and analytical procedure/s for these drugs may not be available in the pharmacopoeia/s. It therefore becomes necessary to develop newer analytical methods for such drugs.
Quality control is a concept, which strives to produce a perfect product by series of measures designed to prevent and eliminate errors at different stages of production. With the growth of pharmaceutical industry during last many years, there has been fast development in the field of pharmaceutical analysis involving complex instrumentation. Providing simple, rapid analytical method for complex formulation is a matter of importance.
Important reasons for the improvement of newer drug analysis methods are:
The drug or combinations of drug may not be official in any pharmacopoeias.
An appropriate analytical method for the drug may not be available in the literature due to patent regulations.
Suitable analytical procedure may not be available for the drug in the form of a formulation due to the interference caused by the formulation excipients.
Analytical method/s for the evaluation of the drug in biological fluids may not be available.
Analytical method for a drug in combination with

Dr. Satish Y. Gabhe, M.Pharm., Ph.D, is a Professor of Pharmaceutical Chemistry in Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India. He worked as a Principal in C.U. Shah College of Pharmacy, S.N.D.T. University, Mumbai. His fields of interest are Synthetic Medicinal Chemistry, Phytochemistry and Analytical Chemistry. During over 27 years of academic experience he tutored a great number of UG/ PG students and Doctoral Research Candidates. He has more than 14 international and 12 national research publications. The author has more than 45 projects completed, 6 ongoing and 3 applied patents. He received a G. S. Ramaswamy Memorial Gold Medal for standing first in the order of merit in B. Pharm. Exam.

Dr. Kakasaheb R. Mahadik, M.Pharm., Ph.D, is a Principal and Professor of Pharmaceutical Chemistry in Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India. He is a member of many professional bodies of India, the American Chemical Society and the New York Academy of Sciences, USA. He is a scientific referee for several central and state government agencies. He has over 30 years of academic experience, during which he guided 22 Doctoral Research Candidates and over 76 M. Pharm. Students in the faculty of Pharmaceutical Sciences. He has published 131 international and 69 national research papers and has 22 Indian patents approved. Furthermore, he is a recipient of several scholarships and awards for his excellence in academics.

Mr. Sachin E. Potawale, M. Pharm. (Ph.D.), is pursuing his Ph.D. from Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India, under the guidance of Dr. Satish Y. Gabhe. Prior to that, the author completed his masters in two specializations (Pharmaceutical Chemistry and Pharmacognosy). He has one year of industrial and one year of academic experience. Currently, he is working as a Project fellow for a University Grants Commission (UGC) sponsored Special Assistance