A new validated stability indicating RP-HPLC method for the simultaneous determination of decitabine and cedazuridine in pharmaceutical dosage form

Title : A new validated stability indicating RP-HPLC method for the simultaneous determination of decitabine and cedazuridine in pharmaceutical dosage form

Abstract:

In the last few decades, several anticancer drugs have been introduced to the market. The introduction of a large number of new drugs and their formulations may lead to the possibility of the distribution of substandard drug products to the consumers. So, stringent quality control of pharmaceuticals is essential for ensuring the availability of quality products to the consumers. The stringent quality control of pharmaceuticals mainly requires the availability of fast, cost-effective, and sensitive modern analytical methods. A combination of Decitabine and Cedazuridine in tablet form is among a recently approved oral anticancer agent. No stability indicating official analytical method was reported for quality control of this recently approved anticancer preparation. Thus, there is a need for the development and validation of a new method to be applicable for routine quality control of the combination in pharmaceutical industries and regulatory authorities. Method validation and forced degradation studies were performed as per the International Conference on Harmonization Guidelines. Separation was conducted on Agilent XDB -C18 (150 mm x 4.6 mm, 3.5µ) column using a mobile phase consisting of mixture of 0.1 % formic acid buffer and acetonitrile (40: 60, v/v), at a flow rate of 1.0 mL min^-1. The developed method was linear for both drugs with a coefficient of determination (R²) > 0.999. The limit of detection (LOD) of the method was 1.05 µgmL^-1 and 3.0 µgmL^-1 for Decitabine and Cedazuridine respectively. The recovery results for the accuracy study were ranged from 98.5% -101.7 %, and the % RSD for the precision results was less than 1.26. A new stability-indicating HPLC method was successfully developed and validated for the assay of both drugs simultaneously, and thus it can be employed for the routine quality control in pharmaceutical industries and regulatory authorities.

Biography:

Dr. Tarekegn Tadesse Unade studied PhD in pharmaceutical sciences at Andhra University India. He then joined Ambo University, department of Pharmacy in Ethiopia serving as assistant professor and researcher. Currently he is conducting research in analytical method development and validation for the determination of drugs in bulk and pharmaceutical dosage forms. Moreover, he is also conducting research in impurity profiling by using different analytical methods.