Prabaharan, P (2017) Method Development and Validation for the Estimation of Decitabine in Pharmaceutical Dosage form by RP-HPLC Method. Masters thesis, R.V.S College of Pharmaceutical Sciences, Coimbatore.
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Abstract
INTRODUCTION: Pharmaceutical analysis is a branch of chemistry involving a process of identification, determination, quantification, purification and separation of components in a mixture or determination of chemical structure of compounds. There are two main types of analysis – Qualitative and Quantitative analysis. Qualitative analysis is performed to establish composition of a substance. It is done to determine the presence of a compound or substance in a given sample or not. The various qualitative tests are detection of evolved gas, limit tests, color change reactions, determination of melting point and boiling point, mass spectroscopy, determination of nuclear half life etc. Quantitative analysis techniques are mainly used to determine the amount or concentration of analyte in a sample and expressed as a numerical value in appropriate units. These techniques are based on suitable chemical reaction and either measuring the amount of reagent added to complete the reaction or measuring the amount of reaction product obtained the characteristic movement of a substance through a defined medium under controlled conditions, electrical measurement or measurement of spectroscopic properties of the compound. AIM: To develop New Rapid, Precise, Accurate RP HPLC method for the estimation of decitabine in pharmaceutical dosage form. PLAN OF WORK: 1. Solubility determination of Decitabine in various solvents and buffers. 2. Determine the absorption maxima of both the drugs in UV–Visible region in different solvents/buffers and selecting the solvents for HPLC method development. 3. Optimize the mobile phase and flow rates for proper resolution and retention times. 4. Validate the developed method as per ICH guidelines. SUMMARY: Each and every day a number of diseases are being diagnosed. Several cancer diseases are on a rise not only for the rich but also for the poor. So, various pharmaceutical organizations are working to develop new drug molecules and new combinations of anticancer drugs for better treatment. This is the reason for a greater competition in the pharmaceutical sector, and the future scenario is likely to be the same. The scope of developing and validating a method is to ensure a suitable strategy for evaluation of a particular analyte which is more specific, accurate and precise. The main focus is drawn to achieve improvement in the manufacturing and analytical conditions and making proper amendments in the standard operating procedures being followed. The above review indicates that there are fewer methods for the estimation of Decitabine in pharmaceutical formulations. But the buffers used in this method was at acidic pH which may affect the column life and some method were with more a run time. So my aim was to develop a new method with minimum run time and less solvent consumption for the estimation of Decitabine in combination of drugs. Hence the present study aims to develop rapid, precise and accurate methods for the determination of Decitabine by RP-HPLC in pharmaceutical dosage forms.CONCLUSION: A new precise, accurate, rapid method has been developed for the simultaneous estimation of Decitabine in pharmaceutical dosage form by RPHPLC. The optimum wavelength for the determination of Decitabine was selected at 244 nm. Various trials were performed with different mobile phases in different ratios, but Ammonium Acetate buffer pH 4.5: ACN (985:15) was selected as good peak symmetry. The Retention time of decitabine was found to be 3.786 min. The different analytical performance parameters such as linearity, precision, accuracy, and specificity, LOD, LOQ were determined according to International Conference on Harmonization ICH Q2B guidelines. The calibration curves were obtained by plotting peak area versus the concentration over the range of 50-150 μg/mL. From linearity the correlation coefficient R2 value was found to be 0.998. The proposed HPLC method was also validated for system suitability, system precision and method precision. The % RSD in the peak area of drug was found to be less than 2%. The number of theoretical plates was found to be more than 2000, which indicates efficient performance of the column. The LOD for this method was found to be 0.0003μg/mL. The LOQ for this method was found to be 0.0009 μg/mL, indicates the sensitivity of the method. The percentage of recovery of was found to be 99.77 shows that the proposed method is highly accurate. Hence the proposed method is highly sensitive, precise and accurate and it successfully applied for the quantification of API content in the commercial formulations of decitabine in Educational institutions and Quality control laboratories.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg. No.261330662 |
| Uncontrolled Keywords: | Decitabine; Pharmaceutical Dosage form ; RP-HPLC Method |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 03 Apr 2018 09:20 |
| Last Modified: | 03 Apr 2018 09:20 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/6827 |
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