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Satish Gabhe, Kakasaheb Mahadik, Sachin Potawale, Anirudh Thati
Simultaneous Estimation of Some Drugs in Bulk and in their Formulation by Chromatographic Methods.
Master's Thesis from the year 2013 in the subject Medicine - Pharmacology, , course: MASTER OF PHARMACY (Quality Assurance Techniques), language: English, abstract: A number of new drug entities, modifications of existing ones, and multi-component formulations are entering the market, every year. Development of simple analytical methods for analysis of various drugs in multi - component formulations is a tricky task for an analytical researcher. As analytical techniques are used throughout drug development, manufacturing, release of drug products, the reliability of their results is essential. Chromatographic methods are most useful and powerful techniques for qualitative and quantitative determination of drug/s. Therefore, appropriate validation to demonstrate the performance and suitability of the analytical method is much more than a formal requirement. Hence, there is need to develop and validate correct analytical method for these medicine/s. This book details, -Development and validation of HPTLC - densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. -Development and validation of HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. -Development and validation of RP - HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is better alternative to existing one. 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) guidelines. Developed analytical methods could boost analytical researcher to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.
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1. Auflage, 2014