Zolmitriptan (4(S)-4-[3-2-dimethyl aminoethyl)-1H-5-indolyl-methyl]-1,3-oxazolan-2-one) belongs to group of medicines known as Serotonin 5-HT1D receptor antagonist. Zolmitriptan is used to treat severe migraine headaches. This cure is available on market as convetional tablets (Zomig), or nasal spray (Zomig nasal spray).

For the determination of pharmaceutical purity of Zolmitriptan, high performance liquid chromatography with spectrophotometric detection is recommended as an analytical technique. The chromatographic separation was achieved on a Waters XTerra RP Column, (250mm, x 4,6 mm, x 5µm) column using linear gradient solutions. As mobile phase – 20 mM ammonium hydrogen orthophosphate and acetonitrile was chosen. In the developed HPLC method, the resolution between Zolmitriptan and its potential impurities, ZL3, ZL4, ZL5, ZL7, werefound to be greater than 3. Obtained product, as pharmaceutical substance, should contain less than 0.5% of total impurities, and no more than 0.10 % of an individual unidentified impurities (acc. ICH). The detection limit (0.5 mg mL^-1) for compoud ZL7 obtained using the developed HPLC method with spectrophotometric detection is unsatisfactory. Because of that, for determination of this compound the different method of analysis need to be used. The developed GC method gave an accepted limit of detection for analysis of this potential impurity (75 ppm). The proposed methods, owing to its satisfactory precision and accuracy as well as selectivity, and can be applied for the determination of impurities in pharmaceutical substance.

• 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/14686 must be provided.

1. Hplc study of Cilostazol tablets: assay and release profile determination
2. Determination of organic volatile impurities in Nepafenac by GC method
3. Application of the new data processing method for photodiode array detector in the analysis of drug substances
4. Improved manufacturing process of bosentan monohydrate.
5. Development and validation of the GC method for quantitative determination of semi-volatile solvents in pharmaceutical substance Bosentan
6. Evaluation of potential genotoxic impurities in prasugrel intermediate by HPLC chromatography
7. Validation of HPLC methods for analyzing the chemical purity of cilostazol
8. Identification of degradation products of cilostazol drug substance
9. Simultaneous CE determination of counterion and possible impurity from synthetic route in pharmaceutical substance prasugrel hydrochloride.
10. Preparation and physicochemical properties of crystalline forms and amorphous pemetrexed disodium
11. An application of accelerator mass spectrometry (AMS) in pediatric clinical studies. Paracetamol, midazolam and spironolactone radiosynthesis and certification.
12. Development and validation of GCMS method for the control of ethyl and izopropyl methanesulphonates in pharmaceutical substance in a form of mesilate
13. Synthesis of potential impurities of loteprednol etabonate and methods for chemical purity determination
14. Assessment of selected synthesis of bosentan towards elimination of known impurities.
15. Comparative permeation studies of tacalcitol through the human skin from brand product versus generic product
16. Development and validation of the HPLC-UV method for impurities determination in duloxetine hydrochloride
17. HPLC methods for in–process control and chemical purity determination of olopatadine
18. Development and validation of HPLC method. Review of selected cases.
19. HPLC method for determination of the enantiomeric purity of a new ω chain aldehyde synthon used in the synthesis of travoprost
20. Synthesis and biological evaluation of new amino acid and dipeptide derivatives of neocryptolepine as anticancer agents. 
21. Analytical control of synthesis and determination of BR-S by HPLC
22. Optimization of BR-8 synthesis
23. Opimisation of preparation of TZ-6
24. HPLC method as an analitycal control of synthesis and determination of TZ-S
25. The synthesis of ezetimibe with high stereochemical purity
26. Investigation of unknown impurity of TD-S by HPLC-MS
27. Validation of a HPLC method for LI-S analysis
28. HPLC Methods for Stress Testing of ZL-S Drug Substances
29. Method development and validation of an analytical procedure - control of residual 2-iodopropane in Latanoprost
30. Zolmitriptan synthesis and in-process control by HPLC methods
31. The cytotoxic activity of glycosides of indolo[2,3-b]quinoline derivatives.
32. Validation of an analytical procedure – control of residual 8 solvents in a pharmaceutical substance
33. HPLC as a method for analytical control of synthesis and determination of tolterodine (TD-S)
34. New rosiglitazone salts
35. Optimization of AR-3 synthesis
36. ROPINIROL - GENERIC DRUG FOR PARKINSON'S DISEASE
37. VALIDATION OF AN ANALYTICAL PROCEDURE - CONTROL OF RESIDUAL ETHANOL, 2-PROPANOL AND ETHYL ACETATE IN PHARMACEUTICAL SUBSTANCE
38. VALIDATION OF AN ANALYTICAL PROCEDURE - CONTROL OF RESIDUAL 9 SOLVENTS IN PHARMACEUTICAL SUBSTANCE
39. CHARACTERIZATION OF ARIPIPRAZOLE SOLVATE WITH ETHANOL AND POLYMORPHIC FORMS PRODUCED DURING ITS HEATING
40. HPLC SEPARATION AND DETERMINATION OF ZIPRASIDONE
41. SYNTHESIS OF GLIMEPIRIDE - CRYSTAL STRUCTURE ANALYSIS STEP BY STEP
42. GC METHOD FOR QUANTITATIVE DETER- MINATION OF RESIDUAL 2-(2-CHLORO- ETOXY)ETHANOL (CEE) AND N-METHYL- 2-PYRROLIDINONE (NMP) IN PHARMACEU- TICAL ACTIVE SUBSTANCE
43. HPLC AS A METHOD FOR ANALYTICAL CONTROL OF SYNTHESIS AND DETERMINATION OF PRAMIPEXOLE
44. THE CYTOTOXIC GLYCOSIDES OF INDOLO[2,3-B]QUINOLINE DERIVATIVES. IN VITRO AND IN VIVO STUDIES
45. ¹H AND ¹³C NMR DATA FOR INDOLO[2,3-b]QUINOLINES - AMINOGLYCOSIDE HYBRIDS, A NOVEL POTENT ANTICANCER DRUG FAMILY .
46. NEW SYNTHESIS OF 11-(1-PIPERAZINYL)- DIBENZO[b,f][1,4]THIAZEPINE, A CRUCIAL INTERMEDIATE IN QUETIAPINE PRODUCTION.
47. THE COMPARISON OF TWO VALIDATED HPLC METHODS FOR THE DETERMINATION OF (+)-CLOPIDOGREL HYDROGENSULFATE PURITY WITH THE USP METHOD.