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Application of RP-HPLC method for stability study and quantifying decitabine in bulk drug and in pharmaceutical dosage form
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| Author:
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SHIV GUPTA, NEETU SACHAN, PHOOL CHANDRA, ARUN KUMAR SHARMA
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| Abstract:
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Aim: The proposed work was selected with an objective to develop a simple, accurate and precise and rapid stability indicating RP-HPLC method and to be validated for quantifying Decitabine in API and its parental preparation.
Method: Method proposed can be utilize for identification of drug Decitabine in reversed phase mode using water’s C18 column maintained at an ambient temperature. A mixture of Acetonitrile: Glacial Acetic Acid (60:40,v/v) and pH was adjusted to 2.5 with O-Phosphoric acid (1 : 100,v/v) was selected as mobile phase with a flw rate of 1.0ml/min at ambient temperature. Detection wavelength was selected at 254nm with injection volume of 20 µl The method was validated according to ICH guideline.
Result: The linearity study reflects that drug was found to beer law between the concentration range of 25-150µg ml-1 with a correlation coefficient (r2)= 0.9997. The LOD and LOQ value for Decitabine were 0.298 and 1.313µg ml-1, respectively, for 20-µL injection volume. Moreover, the drug was exposed to variable stressed conditions and was analyzed by proposed method. Chromatogram reflect no interference from degradative products or exicipients due to variable stress conditions. When the drug was subjected under various stress degradation conditions result reflects that its degradation was highly susceptible to oxidative condition as 28.95% of drug was degraded. In acidic and alkaline conditions, the drug was degraded by 19.68% and 13.14% respectively, while thermal and photolytic condition causes least degradation, i.e. 0.68% and 0.05% respectively.
Conclusion: The proposed method was stable, reproducible, effective, robustic, accurate and linear. Thus can be utilize to quantify Decitabine the quality control of API and its parental preparation.
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| Keyword:
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RP-HPLC, Decitabine, Anti-cancer, Stressed degradative condition
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.04.064
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| Download:
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