HPLC METHOD DEVELOPMENT AND VALIDATION

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PARAMETERS TO BE CONSIDERED WHILE DEVELOPING A NEW HPLC METHOD AND ITS VALIDATION

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DEVELOPMENT AND VALIDATION OF HPLC METHOD:

DEVELOPMENT AND VALIDATION OF HPLC METHOD Seminar By: G.Rajesh Goud ( M.pharm-ph.Analysis ) 12DH1S0403

PowerPoint Presentation:

1. INTRODUCTION Principle : ADSORPTION Modes of separation in HPLC: There are different modes of separation in HPLC like : NORMAL PHASE MODE REVERSE PHASE MODE ION EXCHANGE CHROMATOGRAPHY ION PAIR CHROMATOGRAPHY AFFINITY CHROMATOGRAPHY SIZE EXCLUSION CHROMATOGRAPHY

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Why HPLC is mostly preferred for analyzing most of the drugs ? Which criteria is taken into consideration for developing a new method ? This include : The drug or the drug combination may be not be official in any pharmacopoeias A proper analytical procedure for the drug may not be available in the literature due to patent regulations Analytical methods for a drug in combination with other drugs may not be available

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2. DEVELOPMENT OF NEW HPLC METHOD Following are the points to be taken into consideration while developing a new method: A .EXPERIMENTAL PROCEDURES INSTRUMENTS REAGENTS AND CHEMICALS BUFFERS B.METHOD: SELECTION OF WAVE LENGTH CHROMATOGRAPHIC CONDITIONS PREPARATION OF STANDARD SOLUTION AND CALIBRATION CURVE SAMPLE SOLUTION EVALUATION OF SYSTEM SUITABILITY Under system suitability,,, the following are the parameters to be considered: CAPACITY FACTOR RETENTION TIME RESOLUTION TAILING FACTOR THEORITICAL PLATES REPEATABILITY

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3. VALIDATON OF HPLC METHOD Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. It is the process of defining an analytical requirement, and confirms that the method under consideration has performance capabilities consistent with what the application requires. Use of equipment that is within specification, working correctly and adequately calibrated is fundamental to the method validation process

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Parameters for method validation Selectivity/specificity Precision and reproducibility Accuracy and recovery Calibration Standard deviation of slope ( Sb ) Standard deviation of intercept, (Sa) Correlation coefficient, (r) Linearity and sensitivity of the method Stability Range Limit of detection Limit of quantitation Repeatability Reproducibility Measurement uncertainty Sensitivity Ruggedness (or robustness)

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