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sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
sandeep verapamil ppts
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sandeep verapamil ppts

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  • 1. METHOD DEVELOPMENT AND VALIDATION OF VERAPAMIL BY RP-HPLC 1st IDS PRESENTED BY C.SANDEEP REG.NO:12Y01S0701 Under the guidance of E.PUSHPALATHA REDDY M.Pharm CREATIVE EDUCATIONALSOCIETY’S COLLEGE OF PHARMACY. N.H-7, CHINNATEKUR, KURNOOL-518218, A.P
  • 2. CONTENTS AIM AND OBJECTIVE DRUG PROFILE LITERATURE SURVAY METHOD DEVELOPMENT STEPS IN RP-HPLC INSTRUMENTATION OF RP-HPLC VALIDATION PARAMETERS OF RP-HPLC REFERENCESS
  • 3. AIM AND OBJECTIVE OF STUDY • To develop a simple accurate and precise method for Verapamil in drug substances and drug product and to validate the method as per ICH guidelines.
  • 4. DRUG PROFILE • STRUCTURE: • IUPAC NAME: 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4- dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2 yl)pentanenitrile • MOLECULAR FORMULA: C27H38N2O4
  • 5. • DESCRIPTION: A calcium channel blocker that is a class IV anti-arrhythmia agent. • SOLUBILITY: SOLUBLE IN WATER,METHANOL • MECHANISM OFACTION: Verapamil inhibits voltage- dependent calcium channels. Specifically, its effect on L-type calcium channels in the heart causes a reduction in ionotropy and chronotropy, thuis reducing heart rate and blood pressure. Verapamil's mechanism of effect in cluster headache is thought to be linked to its calcium-channel blocker effect, but which channel subtypes are involved is presently not known.
  • 6. • COLOUR : white cristaline powder • ADDVERS EFFECTS : headache,dizziness,swelling
  • 7. LITERATURE SURVAY 1. iN-VITRO INTERACTION STUDIES OF VERAPAMIL WITH FLUOROQUINOLONES USING FIRST ORDERDERIVATIVE UV SPECTROPHOTOMETRYAND RP-HPLC column: CLC-ODS (6.0 X 150 mm) column. Mobilephase:mobile phase constituted of acetonitrile: water (45:55) Flow rate: 1.2 mL min-1 at 230 nm 2.VALIDATION OF BIOANALYTICAL METHOD FOR VERAPAMIL BY HPLC Column:C-18 column Mobilephase:acetonitrile:potassiumphosphate(45:55)v/v Flow rate:1mi/min
  • 8. 3.METHOD DEVELOPMENT OF VERAPAMIL IN PRESENCE OF NSAIDS USING RP-HPLC METHOD Column:c-18column Mobile phase:mobile phase constituted of acetonitrile: water (45:55) flow rate:2ml/min
  • 9. METHOD DEVELOPMENT STEPS IN RP-HPLC ANALYTICAL METHOD DEVELOPMENT: • Method development usually requires selecting the method requirements and deciding on what type of instrumentation to utilize and why. • The wide variety of equipment, columns, eluent and operational parameters involved makes HPLC method development .
  • 10. There are several reasons for developing new methods of analysis: 1. A suitable method for particular analyte in the specific matrix is not available. 2. Existing methods may be too error or they may be unreliable (have poor accuracy or precision) 3. Existing methods may be too expensive, time consuming.
  • 11. HPLC method development generally follows the following steps: Step 1-selection of the HPLC method and initial system. Step2-Selection of optimum conditions. Step3-selectivity optimization. Step4-system parameter optimization. Step5-method validation.
  • 12. Step 3a Initial HPLC condition Step 2 Sample preparationStep 1 Method goals and chemistry Step 3b Optimize HPLC separation Step 4 Standardization Step 5 Method validation
  • 13. INSRTUMENTATION OF RP-HPLC
  • 14. VALIDATION PARAMETERS OF RP-HPLC Typical validation characteristics which should be considered are listed below:- 1.Accuracy 2. Precision a. repeatability b. intermediate precision 3. specificity 4. Detection limit 5. Quantitation limit 6. Linearity 7. range.
  • 15. REFERENCES 1) Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials, vol. 2, updated editing, Good Manufacturing practices and inspection Geneva, World Health Organization, (2004),16-30. 2) Sharma B. K.,Instrumental methods of chemical analysis, GOLE publishing house (2004),23. 3) Khopkar S. M., Basic concepts of analytical chemistry, New age International Ltd. Publishers, New Delhi, (1998), 2, 178- 179. 4) Settle F., Handbook of Instrumental techniques for analytical chemistry, Prentice Hall PTR, NJ, (1997), 17-19, 56-57.
  • 16. 5)Skoog D. A., F.J. Holler and S.R. Crouch, Principle Of Instrumental Analysis, Thomson Publications, India, (2007), 6, 1-3, 145-147, 180. 6)Mendham J, R.C. Denney, J.D. Barnes, and M. Thomas, Vogel’s Textbook of Quantitative Analysis. Pearson Education, Singapore, (2003), 8-9. 7)Sharma B. K., Instrumental Methods Of Chemical Analysis, Goel Publication Co., Meerut, (1983), 25, 3, 6. 8)Christian G. D., Analytical Chemistry, John Wiley and Sons, (2003), 5, 35-42, 131-132. 9)Michael W. Dong,”Modern HPLC for practicing scientist” A John Wiley & Sons, Inc., Publication, 194,217.
  • 17. Thank You!

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