Decitabine Case Study Solution

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All standard purified materials were used for this study. The solvents which are used in the preparation of solutions should be HPLC grade and obtained from Merck Specialties Private Limited,Mumbai.Active pharmaceutical ingredients Decitabine were supplied by Spectrum Pharma Research Solutions, Hyderabad. [3]The formulation was purchased in a local market. Instrumentation The High performance liquid chromatography system consists of A suitable HPLC having a isocretic system equipped with auto rheodyneinjector , UV detector.

Chromatographic conditions
The chromatographic separation was performed on Develosil ODS HG-5 RP 150mm x 4.6mm 5µm particle size.[4]The column temperature was maintained at 30°c.The mobile phase consisting of Aetonitrile : Acetate
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[12] The percentage recoveries are analyzed of the obtained amount of Decitabine in pharmaceutical formulations.
Method robustness[13,14]
The robustness can be determined by varying the following parameters
1) Flow rate: It can be determined by altering the flow rate from 1 ml/min to 1.2 ml/min. The standard solution of Decitabinewas prepared and was injected by varying the flow rate along with the optimized method.
2) Column temperature: It can be determined by varying the column temperature ±5%. The standard solution of Decitabine was prepared and was injected by changing organic mobile phase composition along with the optimized method.
3) Wavelength: It can be determined by changing the wavelength. The standard solution of Decitabine was prepared and was injected by changing anwavelength along with the optimized method.
LOD and LOQ[17]
Limit of detection (LOD) and limit of quantification (LOQ) of Decitabine was calculated from the calibration curve method. The linearity solutions of Decitabine were prepared and injected. LOD and LOQ were calculated by using following

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