The aim of this study was to develop the chromatographic method (HPLC) for determination of pramipexole and its two impurities: S(-)-4,5,6,7-tetrahydrobenzothiazol-2,6-diamine (DA) and dihydrochloride monohydrate (S)(-)-4,5,6,7-tetrahydro-N⁶,N⁶dipropylbenzothiazole-

2,6-diamine (Imp. A). The chemical structures of tested substances are presented in Figure 1.

Several methods have been tested and finally the method using C18 column and the mobile phase containing 1-octanosufonic acid salt was chosen. The method has been validated and the following parameters were tested: specificity and selectivity, linearity, detection and quantitation limits, precision, intermediate precision, accuracy and robustness. The acceptance criteria were fulfiled.

The method has been applied in testing the stability of pramiexole under stress conditions. The tests included: the effect of oxidation on API and stability in the acidic and alkaline conditions.

It was found that the influence of 1 M HCl on PXS is minimal, the influence of 3 %H ₂O₂ is noticeable and the influence of 1M NaOH is significant. The additional peaks of unknown substances appeared in the chromatograms of the tested solutions.

• Legal notice:
  

  Copyright (c) Pielaszek Research, all rights reserved.
  The above materials, including auxiliary resources, are subject to Publisher's copyright and the Author(s) intellectual rights. Without limiting Author(s) rights under respective Copyright Transfer Agreement, no part of the above documents may be reproduced without the express written permission of Pielaszek Research, the Publisher. Express permission from the Author(s) is required to use the above materials for academic purposes, such as lectures or scientific presentations.
  In every case, proper references including Author(s) name(s) and URL of this webpage: https://science24.com/paper/14967 must be provided.

1. Validation of a HPLC method for LI-S analysis
2. The development of a GC method for analysis of resi- dual acetic acid, triethylamine and N,N-dimethylfor- mamide in hydrochloride salts of pharmaceutical substances
3. Structural characterization of PX-S
4. A novel synthesis of 19-nor analogs of vitamin D
5. The cytotoxic activity of glycosides of indolo[2,3-b]quinoline derivatives.
6. Validation of an analytical procedure – control of residual 8 solvents in a pharmaceutical substance
7. Synthesis of novel pyrido[1,2-c]pyrimidine derivatives as selective ligands for 5-HT_1A receptors
8. Optimization of AR-3 synthesis
9. THE VALIDATION OF ANALYTICAL METHODS OF A PHARMACEUTICAL ACTIVE SUBSTANCE PRODUCED IN SMALL SCALE PLANT (SSP). THE EXAMPLE OF PIOGLITAZONE HYDROCHLORIDE.
10. OPTIMIZATION OF CHIRAL SEPARATION ON VARIOUS POLISACCHARIDE STATIONARY PHASES
11. OPTIMIZATION OF THE CHROMATOGRAPHIC SEPARATION BY HPLC METHOD AND CONFIRMATION OF THE IDENTITY OF CHOSEN ESCITALOPRAM OXALATE INTERMEDIATE PRODUCTS
12. HPLC AS A METHOD FOR ANALYTICAL CONTROL OF SYNTHESIS AND DETERMINATION OF PRAMIPEXOLE
13. MONO SUBSTITUTED 5H-INDOLO[2,3-B]- QUINOLINE DERIVATIVES AND THEIR ABILITY TO OVERCOME THE BARRIER OF DRUG RESISTANCE.
14. A NEW, EFFICIENT AND ECONOMIC METHOD FOR PREPARATION OF PRAMIPEXOLE.
15. ¹H AND ¹³C NMR DATA FOR INDOLO[2,3-b]QUINOLINES - AMINOGLYCOSIDE HYBRIDS, A NOVEL POTENT ANTICANCER DRUG FAMILY .