Stability Indicating Method Development and Validation of Dapsone Using RP-HPLC Technique
Main Article Content
Abstract
Background: Dapsone (DDS) concentrations in both bulk and formulations have been accurately and reliably estimated using the RP-HPLC method.
Method: The research employed an Agilent 1260 Infinity II type high-performance liquid chromatography (HPLC) system. In the mobile phase, a combination of methanol and glacial acetic acid (GAA) in a proportion of 70:30 was used. One millilitre per minute (ml/min), 294 nanometres (nm), and ten minutes of operation time.
Results: Retention time of 3.14 minutes is associated with the DDS peak. The procedure was validated in line with ICH standards. The %RSD for the instrument precision was 0.53%, for the method precision it was 0.58%, and for the intermediate precision it was 0.39%. For concentrations ranging from 40-60 μg/ml, the method was accurate and linear with a r2 value of 0.999. At 80%, 100%, and 120% accuracy, RSD was determined to be 0.30%, 0.33%, and 0.43%, respectively. The stress stability of DDS was investigated, and it was discovered that under oxidation conditions, it degraded by 5.08%, while under photolytic conditions, it degraded by 3.63%.
Conclusion: The established method is suitable for commercial usage. Both the method's resilience and its precision were determined.
Downloads
Article Details
Section
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
The Journal is owned, published and copyrighted by the Nigerian Medical Association, River state Branch. The copyright of papers published are vested in the journal and the publisher. In line with our open access policy and the Creative Commons Attribution License policy authors are allowed to share their work with an acknowledgement of the work's authorship and initial publication in this journal.
This is an open access journal which means that all content is freely available without charge to the user or his/her institution. Users are allowed to read, download, copy, distribute, print, search, or link to the full texts of the articles in this journal without asking prior permission from the publisher or the author.
The use of general descriptive names, trade names, trademarks, and so forth in this publication, even if not specifically identified, does not imply that these names are not protected by the relevant laws and regulations. While the advice and information in this journal are believed to be true and accurate on the date of its going to press, neither the authors, the editors, nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein.
TNHJ also supports open access archiving of articles published in the journal after three months of publication. Authors are permitted and encouraged to post their work online (e.g, in institutional repositories or on their website) within the stated period, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access). All requests for permission for open access archiving outside this period should be sent to the editor via email to editor@tnhjph.com.
How to Cite
References
Vichare V, Handargule P, Tambe V, Dhole S, Choudhari V. Identification of oxidative degradation products of Dapsone in presence of adapalene by RP-HPLC–MS. Chromatographia. 2023 Mar;86(3):223-35. https://doi.org/10.1007/s10337-023-04234-7
Benjamin T, Ramachandran D. Development and validation of RP-LC method for Dapsone in pharmaceutical formulations. World J Pharm Res. 2015;20:1090-9.
Gandhi SV, Patil GR. Development and Validation of Stability Indicating UV Spectroscopic Method for Estimation of Dapsone. International J. of Pharmacy and Biological Sciences. 2019;9(2):406-12. https://doi.org/10.21276/ijpbs.2019.9.2.53
Kohli HK, Ghumare SK, Bagul VA. Development and validation of RP-HPLC method for simultaneous determination of brimonidine and timolol with impurity profiling and forced degradation: application of green tools—AES, AGREE, MoGAPI, RAPI, and BAGI. Accreditation and Quality Assurance. 2026 Apr;31(2):119-46. https://doi.org/10.1007/s00769-026-01697-7
Leistner A, Holzgrabe U. Impurity profiling of dapsone using gradient HPLC method. Journal of Pharmaceutical and Biomedical Analysis. 2021 May 10;198:113982. https://doi.org/10.1016/j.jpba.2021.113982
Beheshti-Maal L, Navidpour L, Afshar M. An ecofriendly and stability-indicating RP-HPLC method for determination of dapsone: Application to pharmaceutical analysis. Chiang Mai J Sci. 2016 Apr 1;43(3):420-629.
Samy B, Mabrouk MM, Hamid MA, Ahmed HM. Eco-friendly, stability-indicating micellar HPLC-UV method for simultaneous determination of clindamycin phosphate and adapalene in gel formulations. BMC chemistry. 2025 Dec;19(1):307. https://doi.org/10.1186/s13065-025-01669-x
Ahmad S, Ashwin B, Rahman BA, Gorad RU. Quality by design (QBD) approach to develop stability indicating RP-HPLC method development for naproxen and pantoprazole. International journal of health sciences. 2022;6(S4):11450-65. https://doi.org/10.53730/ijhs.v6nS4.11131
Colomé LM, Freitas GM, de Medeiros Bastiani J, Pereira TC, Bajerski L, Bender EA, Haas SE. Validation of analytical method by HPLC for determination of dapsone in polymeric nanocapsules based on crude rice brain oil. Journal of Applied Pharmaceutical Science. 2017 Jul 30;7(7):230-3. https://doi.org/10.7324/japs.2017.70734
Deshpande M, Shaikh F, Sable V, Patil K, Holam MR. New stability indicating RP-HPLC method for estimation of the drug molnupiravir. Int. J. Pharm. Qual. Assur. 2023 Mar 25;14:149-58. https://doi.org/10.25258/ijpqa.14.1.26
Philip PA, Roberts MS, Rogers HJ. A rapid method for determination of acetylation phenotype using dapsone. British journal of clinical pharmacology. 1984 Apr;17(4):465-9. https://doi.org/10.1111/j.1365-2125.1984.tb02373.x
Eljaschewitsch J, Padberg J, Schürmann D, Ruf B. High-performance liquid chromatography determination of pyrimethamine, dapsone, monoacetyldapsone, sulfadoxine, and N-acetyl-sulfadoxine after rapid solid-phase extraction. Therapeutic drug monitoring. 1996 Oct 1;18(5):592-7. https://doi.org/10.1097/00007691-199610000-00012
Kabra RP, Kadam SC, Mane VB, Kadam SS, Mamde CG. Simple novel UV-spectroscopic method for estimation of ezetimibe in tablet dosage form. Am. J Pharm Health Res. 2014;2(9).
Sarsam LA. Spectrophotometric and high performance liquid chromatographic methods for the determination of dapsone in a pharmaceutical preparation. Rafidian J Sci. 2013 Jan 1;24:128-45. https://doi.org/10.33899/rjs.2013.67587
Pund S, Nalawade S, Rajurkar V, Jayatpal S, Deshmukh N. A brief review on recent advances in reverse phase HPLC. Multidiscip Rev. 2024 Jan 18;7(4):2024072. https://doi.org/10.31893/multirev.2024072
Sarfraz S, Hussain S, Javed M, Raza A, Iqbal S, Alrbyawi H, Aljazzar SO, Elkaeed EB, Somaily HH, Pashameah RA, Alzahrani E. Simultaneous HPLC determination of clindamycin phosphate, tretinoin, and preservatives in gel dosage form using a novel stability-indicating method. Inorganics. 2022 Oct 10;10(10):168. https://doi.org/10.3390/inorganics10100168
Ahmad S, Khairnar M, Bakhshi AR, Tare M, Baheti D, Tare H. QBD approach to develop stability indicating RP-HPLC method development for Levosulpiride and Ilaprazole. International Journal of Health Sciences. 2022;6(S5):7413-29. https://doi.org/10.53730/ijhs.v6nS5.11625
Sutar SV, Yeligar VC, Patil SS. Stability Indicating Forced Degradation Studies. Research Journal of Pharmacy and Technology. 2019;12(1):429-33. https://doi.org/10.5958/0974-360X.2019.00078.7