Introduction:
Malaria, an infectious disease caused by protozoa of the genus Plasmodium, is
highly prevalent in the Brazilian Amazon. Chloroquine is the first-choice drug for the treatment of malaria
caused by P. vivax and P. malariae. The humid and hot climate characteristic of the Brazilian
endemic region favors drug degradation and modification of its biopharmaceutical properties, which
may result in subtherapeutic dosage, formation of degradation products that can be toxic to humans and
appearance of parasitic resistance. Thus, it is necessary to monitor the quality of chloroquine tablets.
Materials and Methods:
An analytical method was developed and validated to determine chloroquine
content in tablets by ultraviolet spectrophotometry. The diluent consisted of 0.06 M monosodium phosphate
buffer pH 6.8 and detection was performed at 343 nm.
Results and Conclusion:
The method proved to be linear in the range of 7.2 to 19.2 µg.mL-1, precise,
accurate, selective, robust, and statistically equivalent to a liquid chromatographic method by the United
States Pharmacopeia. The developed method was applied to determine chloroquine content in six
batches of the drug. The evaluated batches were considered adequate for identification, assay, dissolution,
disintegration and uniformity of dosage units, and were found to be inadequate in terms of friability.
A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star ® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min -1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust, and was adequate for stability studies and routine quality control analyses of DTZ in tablets and compounded capsules.
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