Method Development and Validation for Anti Diabetic Drugs by RP-HPLC

Yamuna Pradeepa, J (2015) Method Development and Validation for Anti Diabetic Drugs by RP-HPLC. Masters thesis, Edayathangudy.G.S Pillay College of Pharmacy, Nagapattinam.


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INTRODUCTION:Analytical chemistry may be defined as the science and art of determining the composition of materials in terms of the elements of composition contained. Pharmaceutical analysis is a bench of science that deals with the analytical procedures used to determine the purity, safety and quality of drugs and chemicals. It contains procedures to determine the identity , strength , quality and purity of new compounds . It also involves procedures for separating, identifying, and determining the relative amount of the components in sample of matter. Quality assurance plays a key role in finding the safety and efficiency of medicines. It has highly specific and sensitive analytical methods for the design , development, standardization and quality control of medicinal products . They are equally important for the pharmacokinetics and drug metabolism studies, both which are important for the assessment of bioavailability and clinical response.AIM AND PLAN OF WORK:The drug analysis is playing an important role in the development of drugs, their manufacture and therapeutic use. For the simultaneous estimation of drugs present in dosage forms , lot of suitable methods are adopted like uv – spectrophotometer , HPLC , HPTLC etc .These methods are powerful and rugged method .They are also extremely precise, specific, accurate, linear and rapid. A pharmaceutical industry depends upon quantitative chemical analysis to ensure that the raw material used and the final product obtained meets the required specification. The drugs will occur as a single component or multi component dosage forms. The later proves to be effective due to its combined mode of action on the body. The number of drugs or drug formulations introduced into the market is increasing at a fast rate .These may be either new entries in the market or structural modification of the existing drugs or novel dosage forms or multi component dosage forms .The complexity in the dosage forms, including that of the multi component dosage forms creates considerable challenges to the analytical chemist during the development of assay procedure for its accurate estimation. The estimation of individual drugs in these multi component dosage forms becomes difficult due to tedious extraction or isolation procedure. The combination of Metformin HCL and Sitagliptin was selected for the present study. According to the literature survey conducted, it was observed that no method was reported in RP-HPLC for the estimation of individual drug carried out. Hence present study aims to develop an accurate, precise, specific, linear, simple, rapid, validated and cost effective analytical method for Metformin HCL and Sitagliptin in tablet dosage form by RP-HPLC method. The scope of our work extends to validate for the developed method as per ICH guidelines.RP-HPLC method development was obtained as 1. Selection and optimization of mobile phase and stationary phase. 2. Selection of detector wavelength. 3. Selection of extraction procedure. 4.Optimization of chromatographic condition. 5. Estimation of Metformin HCL and Sitagliptin 6.Method validation. SUMMARY AND CONCLUSION:RP-HPLC method was developed. It was validated for the estimation of Metformin HCL and Sitagliptin in tablet dosage form using HPLC Shimadzu Prominence with UV-Visible SPD 20A Detector and Phenominex C18 (250x4.6mm, 5μ) column, injection of 20 μl is injected and eluted with the mobile phase of dipotassium hydrogen phosphate buffer, and acetonitrile in the ratio 55:45, which was pumped at a flow rate of 1ml at 260 nm. The peak of Metformin HCL and Sitagliptin are found well separated at 4.285 and 7.485 respectively. The developed method was validated for various parameters as per ICH guidelines like Accuracy, Precision, Linearity, Specificity, Ruggedness, Robustness, LOQ and LOD. The analytical method validation of Metformin HCL and Sitagliptin by RP HPLC method was found to be satisfactory and could be used for the routine pharmaceutical analysis of Metformin HCL and Sitagliptin .

Item Type: Thesis (Masters)
Additional Information: Reg. No. 261330961
Uncontrolled Keywords: Method Development ; Validation ; Anti Diabetic Drugs ; RP-HPLC
Subjects: PHARMACY > Pharmaceutical Chemistry
Depositing User: Ravindran C
Date Deposited: 19 Mar 2018 08:39
Last Modified: 19 Mar 2018 08:39

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