Abstract :
Aim: The aim is to study the development of a methodology for the quantitative determination of meloxicam and indole-3-carbinol in the developed rectal suppositories, which would allow the effects of the matrix, placebo, and accompanying impurities on the course of the determination to be cutoff. Materials and Methods: Indole-3-carbinol (Sigma-Aldrich Co., USA) and meloxicam (Boehringer Ingelheim GmbH, Germany) as well as developed rectal suppositories with a combination of given active pharmaceutical ingredients in the amount for 1 suppository: Indole-3-carbinol - 0.2 g and meloxicam - 0.0075 g were used In carrying out the studies, meloxicam PRS was used, corresponding to the requirements of the European Pharmacopoeia. To determine the content of indole-3-carbinol, a reagent with a purity of at least 99% was used. To calculate the quantitative content of meloxicam and indole-3-carbinol, the homogeneity values obtained for the 10 samples studied are used. The measurements were carried out by high-performance liquid chromatography (HPLC) according to SPU, supp. 1, 2.2.29, N. The validation of the methodology was carried out in accordance with the requirements of SPU according to individual validation characteristics: Specificity, linearity, repeatability, precision, accuracy, and intralaboratory precision. Results and Discussion: According to the developed technique, the quantitative determination of meloxicam and indole-3-carbinol in the composition of rectal suppositories has been studied. The following results were obtained: With the content of meloxicam in one dosage unit of the test preparation is 0.0078 g and the content of indole-3-carbinol - 0.205 g, which indicates the validity of the proposed procedure for the quantification of active substances in suppositories for the prevention and treatment of benign prostatic diseases. Conclusions: In the course of the study, a HPLC technique with a gradient elution mode has been developed. It has been established that the selected chromatographic conditions allow not only quantitatively determine the substances under investigation in the finished dosage form but also estimate the uniformity of their distribution. The validation of the developed method has been carried out, and its suitability for simultaneous quantitative determination of both meloxicam and indole-3-carbinol in a dosage form was proved.
Keyword :
Key words: High-performance liquid chromatography, indole-3-carbinol, meloxicam, quantitative determination, rectal suppositories, validation