UNDER THE GUIDANCE OF: Dr.Ravindranath. HOD,Pharmaceutical Analysis.

1. “DEVELOPMENT AND VALIDATION OF SIMPLE ANALYTICAL METHODS FOR THE ESTIMATION OF MOXIFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORM” UNDER THE GUIDANCE OF: Dr.Ravindranath. HOD,Pharmaceutical Analysis. PRESENTED BY:G.Ashwini Regd no.100809885003 M. PHARM IN PHARMACEUTICAL ANALYSISDISSERTATION www.pharmacygraduates.org

2. TABLE OF CONTENTS www.pharmacygraduates.org

3. INTRODUCTION Pharmaceutical analysis comprises the procedures necessary to determine the identity, strength, quality and purity of substances of therapeutic importance. Quality is important in every product or service, but it is vital in medicines as it involves life. Analytical techniques that are generally used for drug analysis are Chromatographic methods, Spectral methods, Biological and Microbiological methods. www.pharmacygraduates.org

4. Validation of Analytical Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. The various validation parameters are: • Accuracy, • Precision (Repeatability and Reproducibility), • Linearity and Range, • Limit of detection (LOD) / Limit of quantitation (LOQ), • Selectivity / Specificity, • Robustness / Ruggedness, • Stability and System suitability studies www.pharmacygraduates.org

5. DRUG PROFILE • Moxifloxacin is a fourth-generation synthetic fluoroquinolone antibacterial agent www.pharmacygraduates.org

6. Nomenclature:1-cyclopropyl-7-[(1s,6s)-2,8-diaz[4.3.0]non-8-yl]-6-fluoro-8-methoxy-4-oxo-quinoline carboxylic acid • Molecular formula : C21H24F N3O4.HCL.. • Molecular weight : 401.431 g/mol . • Appearance : It occurs as a Yellow to yellow crystalline substance • Solubility : It is soluble in methanol, sparingly soluble in water and practically insoluble in acetone. • Category : Antibacterial agent. www.pharmacygraduates.org

7. OBJECTIVES The Objective of this dissertation work is as follows • Aim of the present work is to Develop some new analytical methods for the estimation of moxifloxacin in bulk and drug formulations • To Develop rapid, sensitive and selective method • Economic and accurate method • Method validation according to ICH guidelines. www.pharmacygraduates.org

8. INSTRUMENTATION • HPLC is one mode of chromatography, • Chromatographic processes can be defined as separation techniques involving mass-transfer between stationary and mobile phases. • HPLC utilizes a liquid mobile phase to separate the components of a mixture. • These components (or analytes) are first dissolved in a solvent, and then forced to flow through a chromatographic column under high pressure. In the column, the mixture is resolved into its components. • As a result, HPLC acquires a high degree of versatility not found in other chromatographic systems and has the ability to easily separate a wide variety of chemical mixtures. www.pharmacygraduates.org

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10. BLOCK DIAGRAM OF HPLC: www.pharmacygraduates.org

11. METHODOLOGY PART A: UV SPECTROSCOPY • Selection of analytical wavelength • Preparation of stock solutions • Calibration curve for the Moxifloxacin • Sample preparation for determination of Moxifloxacin from dosage form • Validation of Spectrophotometric methods www.pharmacygraduates.org

12. PA RT B: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY • Gather / generate background information – obtain Physico-chemical properties, • Determine, if special handling / treatment of sample is needed, • From physic-chemical properties select detector, • Select LC mode and perform initial runs, • Optimize separation conditions; peak Rs , equation parameters, • Summarize methodology finalize documentation, • Validate method / Transfer to control Laboratory. www.pharmacygraduates.org

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15. Optimized Chromatographic Conditions for HPLC www.pharmacygraduates.org

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17. Reference • Validated spectrophotometric methods for the estimation of moxifloxacin in bulk and pharmaceutical formulations. Motwani SK, Chopra s, Ahmad FJ, Khar RK. Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India. sanjay_bcp@rediffmail.com Validated spectrophotometric methods for the estimation of moxifloxacin in bulk and pharmaceutical formulations References and further reading may be available for this article. Sanjay K. Motwani, Shruti Chopra Farhan J. Ahmad1 and Roop K. Khar1, a aDepartment of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India www.pharmacygraduates.org

18. Optimization and validation of the direct HPLC method for the determination of moxifloxacin in plasma Aleksandra Laban-Djurdjevića, Milena Jelikić-Stankovb and Predrag Djurdjević aMedicines and Medical Devices Agency of Serbia, V. Stepe 458, 11152 Belgrade, Serbia and MontenegrobFaculty of Pharmacy, V. Stepe 450, 11152 Belgrade, Serbia and MontenegrocFaculty of Science, P.O. Box 60, 34000 Kragujevac, Serbia and Montenegro • Web sites: www.pubmed.com www.sciencedirect.com www.google.com www.pharmacygraduates.org www.pharmacygraduates.org

19. THANK YOU www.pharmacygraduates.org