1Bulgarian Drug Agency, BULGARIA
2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Medical University-Sofia, BULGARIA
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ABSTRACT
Background
One of the organisational strategies to ensure the use of relevant good practises for each stage in the life cycle of pharmaceutical products is the market surveillance program, which aims to demonstrate product specification adherence. It uses analytical pharmacopoeial and literature-based approaches primarily to carry out quality control on the chosen pharmaceutical items.
Aim
Development of a program for analytical control of different medicinal products containing 25 mg hydrochlorothiazide.
Materials and Methods
European Pharmacopoeia and USP HPLC methods for assay and related substances were applied in prescription medicines.
Results
The system suitability tests were evaluated for each method, and the results of each generated group of products were compared. The quantitative content values deviation and the quantitative limitations for each impurity were determined. The deviations are in the range 0.76%-4.01%. Calculated RSD values are below 2%. The results obtained by both methods are within the acceptable limits of 95%-105%. In the European Pharmacopoeia method, the limits of three impurities were determined and seven more were found and marked as unknown. The USP method allows identification of only one impurity.
Conclusion
For the market surveillance program for pharmaceuticals containing hydrochlorothiazide, an analytical control program has been developed. The program combines multiple pharmacopoeial HPLC methods and compares the outcomes with an initial assessment of each method’s applicability for all pharmaceuticals containing hydrochlorothiazide.