Stability Indicating RP-HPLC (PDA) Method Development and Validation for the Quantification of Trientine Hydrochloride and Characterisation of its Degradation Product by Spectroscopic Techniques

Varalakshmi, A (2019) Stability Indicating RP-HPLC (PDA) Method Development and Validation for the Quantification of Trientine Hydrochloride and Characterisation of its Degradation Product by Spectroscopic Techniques. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.


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In the present study a new stability indicating RP-HPLC method has been developed and validated for the quantification of Trientine hydrochloride. The developed method was validated as per ICH guidelines. The parameters which are validated are linearity, accuracy, precision, robustness and system suitability parameters. The chromatographic conditions were optimized before the development of the chromatogram. The mobile phase consisted of a mixture of pH 5.3 ammonium formate buffer and acetonitrile (90:10v/v) under gradient mode of elution. The system suitability parameters such as theoretical plates, tailing factor and peak symmetry were determined to check the validity of the developed RP-HPLC method. The developed chromatographic method proved to be superior to most of the reported methods in terms of accuracy, precision and sensitivity. The data obtained was subjected to statistical analysis. The proposed method was successfully applied to the determination of the selected drug in its pharmaceutical dosage form. The stability indicating RP-HPLC method is useful to understand the degradation behaviour of Trientine hydrochloride. Trientine hydrochloride was subjected to forced degradation study. TNT was found to degrade in oxidative stress conditions and the degradation product was characterised by IR, Mass and NMR spectroscopic techniques. Toxicity of the degradation product was checked by using Osiris software. It was found that the degradation product is non-toxic. Prediction results are colour coded in which the red colour shows high risks with undesired effects like mutagenicity or poor intestinal absorption and green colour indicates drug-conform behaviour. The proposed method is accurate, selective, sensitive and reproducible.The method is relatively free from any interference produced from common tablet excipients. Hence, the recommended procedure is well suited for the assay and evaluation of TNT in pharmaceutical quality control. The present work can be extended for the quantification of the selected drug in bioavailability, bioequivalence, pharmacokinetics, in-vitro and in-vivo correlation studies. A successful analyst must know what reactions are taking place during analysis and be able to understand and apply the theory upon which the method is dependent. The analyst must acquire skills of technique, patience, neatness and accuracy. Absolute integrity is demanded of every quantitative analyst. To become a sucessful analyst, one must realize that, analytical chemistry is not a simple routine procedure. Manipulative skill acquired by experience with the ability to follow directions under the supervision of a skilled analyst may enable one to carry out successfully certain analytical procedures.

Item Type: Thesis (Masters)
Additional Information: 261715708
Uncontrolled Keywords: RP-HPLC (PDA) Method, Development, Validation, Quantification, Trientine Hydrochloride, Characterisation, Degradation Product, Spectroscopic Techniques
Subjects: PHARMACY > Pharmaceutical Chemistry
Depositing User: Ramakrishnan J
Date Deposited: 11 May 2022 06:52
Last Modified: 11 May 2022 06:52

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