Development and Validation of Chromatographic Methods for Simultaneous Quantification of Drugs in Bulk and in Their Formulations

This book details: 1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. 2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. 3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones. The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.

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 Programme. He has published 20 international and 6 national research papers and 10 review articles. He has presented several posters in various international and national seminars. Mr. Anirudh B. Thati, M.Pharm, has completed his masters in Quality Assurance Techniques from Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India. He has also completed a certification course in Pharmacovigilance conducted mutually by Vigimedsafe and BITS Pilani, Hyderabd. Currently, he is working at the Regulatory Affairs department of Emcure Pharmaceuticals Limited, Pune, India. He has presented several posters in various international and national symposiums and attended workshops on chromatographic equipment.