Skip to content
2000
  1. Home
  2. A-Z Publications
  3. Current Pharmaceutical Analysis
  4. Volume 20, Issue 6
  5. Article
Volume 20, Issue 6
  • ISSN: 1573-4129
  • E-ISSN: 1875-676X

Abstract

Background

In the current study, a simple and cost-effective stability-indicating RP-HPLC method was developed and validated to estimate the mesalamine from both bulk and pharmaceutical dosage forms.

Methods

An isocratic HPLC method using a reverse phase HiQSilC18 column (250 x 4.6 mm, 5µm) and a mobile phase methanol: ammonium acetate buffer (90:10 v/v) were employed as the mobile phase with a flow rate of 1 mL/min at 25°C. Detection was carried out at 305 nm, and the injection volume was 20μl. The developed method was validated as per ICH Q2 guidelines. Mesalamine has been subjected to various stress testing conditions, such as hydrolysis of acid and base, thermal degradation, oxidation, and photolysis. Also, methods have been validated with regard to linearity, accuracy, precision, and robustness.

Results

The RT of mesalamine was determined to be 3.550 min ± 0.024 minutes, providing a reliable marker for its identification. The method was found to be linear between 5-30 μg/mL concentration with (R2) of 0.994. This demonstrated the method's ability to measure varying concentrations of mesalamine accurately. Additionally, the percentage recovery of mesalamine was approximately 100%, confirming the accuracy of the developed method. The parameters for system suitability have also been found to be within acceptable limits. Force degradation studies reinforced the method's selectivity and sensitivity in detecting mesalamine under various degradation scenarios. Notably, mesalamine significantly degraded in an acidic environment.

Conclusion

In conclusion, our proposed RP-HPLC method provides a sensitive, accurate, and precise means of analyzing mesalamine in both bulk and pharmaceutical dosage forms.

© 2024 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/cpa/10.2174/0115734129308140240715052552
2024-07-01
2024-10-18

  • From This Site

    /content/journals/cpa/10.2174/0115734129308140240715052552
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. WuX. LiuX. KatzS. ShenB. Pathogenesis, diagnosis, and management of ulcerative proctitis, chronic radiation proctopathy, and diversion proctitis.Inflamm. Bowel Dis.201521370371510.1097/MIB.0000000000000227 25687266
     [Google Scholar]
  2. GecseK.B. LakatosP.L. Ulcerative proctitis: an update on the pharmacotherapy and management.Expert Opin. Pharmacother.201415111565157310.1517/14656566.2014.920322 24837209
     [Google Scholar]
  3. LametM. A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis.Dig. Dis. Sci.201156251352210.1007/s10620‑010‑1334‑y 20676771
     [Google Scholar]
  4. HeymanM.B. KierkusJ. SpénardJ. ShbakloH. GiguereM. Efficacy and safety of mesalamine suppositories for treatment of ulcerative proctitis in children and adolescents.Inflamm. Bowel Dis.201016111931193910.1002/ibd.21256 20848454
     [Google Scholar]
  5. YadavA.V. YadavB.V. Improvement of physicochemical properties of mesalamine with hydrophilic carriers by solid dispersion (kneading) method.Res. J. Pharm. Technol.20081422425
     [Google Scholar]
  6. NielsenO.H. MunckL.K. Drug Insight: aminosalicylates for the treatment of IBD.Nat. Clin. Pract. Gastroenterol. Hepatol.20074316017010.1038/ncpgasthep0696 17339853
     [Google Scholar]
  7. CurkovicI. EgbringM. Kullak-UblickG.A. Risks of inflammatory bowel disease treatment with glucocorticosteroids and aminosalicylates.Dig. Dis.2013313-436837310.1159/000354699 24246990
     [Google Scholar]
  8. ZeeshanM. AliH. KhanS. KhanS.A. WeigmannB. Advances in orally-delivered pH-sensitive nanocarrier systems; an optimistic approach for the treatment of inflammatory bowel disease.Int. J. Pharm.201955820121410.1016/j.ijpharm.2018.12.074 30615925
     [Google Scholar]
  9. ZuM. MaY. CannupB. XieD. JungY. ZhangJ. YangC. GaoF. MerlinD. XiaoB. Oral delivery of natural active small molecules by polymeric nanoparticles for the treatment of inflammatory bowel diseases.Adv Drug Deliv Rev202117611388711810.1016/j.addr.2021.113887
     [Google Scholar]
  10. SonuI. LinV. BlonskiW. LichtensteinR. Clinical pharmacology of 5-ASA compounds in inflammatory bowel disease.Gastroenterology Clinics20101;393559599
     [Google Scholar]
  11. SandbornW.J. The present and future of inflammatory bowel disease treatment.Gastroenterol. Hepatol. (N. Y.)2016127438441 27489526
     [Google Scholar]
  12. DavisE.M. ZhangD. GloverS.C. StappenbeckT. WangS. LiuJ.J. P128 inhibition of intestinal epithelial cell pyroptosis and associated mucosal barrier defects is a potential therapeutic mechanism of action for mesalamine in IBD.Gastroenterology20191563S8810.1053/j.gastro.2019.01.204
     [Google Scholar]
  13. DestroF. BaroloM. A review on the modernization of pharmaceutical development and manufacturing – Trends, perspectives, and the role of mathematical modeling.Int. J. Pharm.202262062012171510.1016/j.ijpharm.2022.121715 35367580
     [Google Scholar]
  14. FayaziM. Ghanei-MotlaghM. TaherM.A. Combination of carbon nanotube reinforced hollow fiber membrane microextraction with gas chromatography-mass spectrometry for extraction and determination of some nitroaromatic explosives in environmental water.Anal. Methods201356147410.1039/c3ay25644h
     [Google Scholar]
  15. BhutaniH. KurmiM. SinghS. BegS. SinghB. Quality by design (QbD) in analytical sciences: An overview.Pharm. Times200433945
     [Google Scholar]
  16. KolsureA. DanielK. BhatM. Analytical methods for estimation of Budesonide in bulk and in Pharmaceutical dosage forms: A Review.Res. J. Pharm. Technol.20211452873287710.52711/0974‑360X.2021.00505
     [Google Scholar]
  17. NobilisM. VybíralováZ. SládkováK. LísaM. HolčapekM. KvětinaJ. High-performance liquid-chromatographic determination of 5-aminosalicylic acid and its metabolites in blood plasma.J. Chromatogr. A200611191-229930810.1016/j.chroma.2006.01.058 16466733
     [Google Scholar]
  18. MoharanaA.K. BanerjeeM. SahooC.K. SahooN.K. Development and validation of RP-HPLC method for mesalamine.Asian J. Pharm. Clin. Res.2011427173
     [Google Scholar]
  19. KanubhaiT.R. Mukesh CP. Amit RK. Determination of mesalamine related Impurities from drug product by reversed phase validated UPLC Method.E-J. Chem.20118113114810.1155/2011/382137
     [Google Scholar]
  20. SahooN.K. SahuM. Srinivasa RaoP. GhoshG. Validation of stability indicating RP-HPLC method for the estimation of mesalamine in bulk and tablet dosage form.Pharm. Methods201342566110.1016/j.phme.2013.12.003
     [Google Scholar]
  21. MoharanaA.K. BanerjeeM. PandaS. MuduliJ.N. Development and validation of UV spectrophotometric method for the determination of mesalamine in bulk and tablet formulation.Int. J. Pharm. Pharm. Sci.2011321921
     [Google Scholar]
  22. Harmonized Tripartite GuidelineI.C.H. Text on validation of analytical procedures, text and methodology, Q2(R1).International Conference on HarmonizationGeneva2005117
     [Google Scholar]
  23. GuptaS. VermaP. MishraA. OmarN. MathurR. A review on novel analytical method development and validation by RP-HPLC method.Indian J. Forensic Med. Toxicol.202215434763486
     [Google Scholar]
  24. AhmadS. DeepikaS. AmolP. KapilW. UsmanM.M.R. Novel RP-HPLC method development and validation of meloxicam suppository.Indian J. Pharm. Educ. Res.201751464464910.5530/ijper.51.4.95
     [Google Scholar]
  25. NagasarapuM.R. DannanaG.S. Development and validation of stability indicating RP-HPLC method for the estimation of cinacalcet hydrochloride in bulk and their formulations.Biointerface Res. Appl. Chem.20201066610661810.33263/BRIAC106.66106618
     [Google Scholar]
  26. MuthukumarS. SujithaK. NavanethanJ. SelvakumarD. DavidB. Method development and validation of RP-HPLC method for simultaneous determination of clindamycin phosphate and clotrimazole in soft gelatin vaginal suppositories.IJPT201344270275
     [Google Scholar]
  27. Harmonized Tripartite GuidelineI.C.H. Stability testing of new drug substances and products, Q1A(R2).International Conference on HarmonizationGeneva2003124
     [Google Scholar]
  28. SaadatiN. AbdullahM.P. ZakariaZ. SanyS.B. RezayiM. HassonizadehH. Limit of detection and limit of quantification development procedures for organochlorine pesticides analysis in water and sediment matrices.Chem. Cent. J.20137121010.1186/1752‑153X‑7‑63
     [Google Scholar]
  29. BandaruS.P.K. MukthinuthalapatiM.A. Development and validation of a new stability indicating RP-HPLC method for the quantification of Budesonide in pharmaceutical dosage forms in presence of an internal standard.Res. J. Pharm. Technol.20221552103210910.52711/0974‑360X.2022.00349
     [Google Scholar]
  30. KowalskaM. WoźniakM. KijekM. MitroszP. SzakielJ. TurekP. Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product.Sci. Rep.20221211910.1038/s41598‑021‑99269‑x 34992227
     [Google Scholar]
  31. HaqueS.K.M. Box–Behnken experimental design for optimizing the HPLC method to determine hydrochlorothiazide in pharmaceutical formulations and biological fluid.J. Mol. Liq.202235211870810.1016/j.molliq.2022.118708
     [Google Scholar]
  32. DalalA. TegeliV. WaghmodeR. RP-HPLC method development and validation for the estimation of Brivaracetam in bulk and formulation.Int. J. Adv. Sci. Res.20221377983
     [Google Scholar]
/content/journals/cpa/10.2174/0115734129308140240715052552
Loading
Determination of Mesalamine in Bulk and Suppository Dosage Forms through the Development and Validation of Stability- indicating RP-HPLC Method
Current Pharmaceutical Analysis 20, 433 (2024); https://doi.org/10.2174/0115734129308140240715052552
/content/journals/cpa/10.2174/0115734129308140240715052552
/content/journals/cpa/10.2174/0115734129308140240715052552
Loading

Data & Media loading...

  • Article Type: Research Article
Keyword(s): ICH guidelines; Mesalamnie; RP-HPLC; stability-indicating; suppository; validation

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test