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Stream/Area:
-
Subject:
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Paper ID:
IJSREM65022
Volume:
10 |
6 |
Jun 2026
Pages:
1-13
Publication Frequency:
Monthly (12 issues per year)
License:International Journal of Scientific Research in Engineering and Management follows the Creative Commons Attribution 4.0 (CC BY 4.0) License, allowing free use and distribution with proper attribution.
Quality Assurance
RBTB
Dept. of Pharmaceutical Science,
Rajesh Bhaiyya Tope College of Pharmacy, Chh.Sambhajinagar
Dept. of Pharmaceutical Science,
Rajesh Bhaiyya Tope College of Pharmacy, Chh.Sambhajinagar
Dept. of Pharmaceutical Science,
Rajesh Bhaiyya Tope College of Pharmacy, Chh.Sambhajinagar
ASAQ combination drug used in treating malaria is bitter in taste, resulting in poor adherence and difficulty in swallowing by children. To mitigate this issue, taste masking is achieved by coating the drug with polymers to improve the taste of the dosage form. However, this produces a novel drug product which must undergo analytical evaluation to ensure that it is safe and drug content matches the label claim. The aim of this study is to develop and validate a novel analytical methodology which is suitable for this purpose. Thus, a reversed phase high performance liquid chromatography for the quantitative determination of AS and its impurities was developed. The method was validated according to ICH guidelines for linearity, precision, accuracy, and specificity, limit of detection (LOD) and limit of quantification (LOQ). The method was found accurate and precise with an average retention time of 8.2 min. Good linearity was observed in the concentration range of 0.25 – 0.75 mg/ml with regression coefficient of r2 =0.999. The assay of the proposed method was found to be 101.5%. The recoveries of artesunate were found to be within 99% - 102%. The % RSD for precision was found to be
KEYWORDS
The ideal objective was to develop a simultaneous method for AS, AQ and its impurities. Due to the complexity as some analytes were coeluting, separate method for AS with impurities and AQ with impurities was developed. In total three analytical methods were developed for the monitoring of AS and its impurities, AQ and its impurities and HPLC method for dissolution samples for a novel taste mask coated ASAQ formulation developed by Fluid Pharma Ltd. Acceptable recovery of API from the formulation was found when using methanol as an extraction solvent for artesunate and methanol: water (80:20) as an extraction solvent for amodiaquine. Validation took place, with all tested parameters were found to be within the limits stated in the ICH guidelines. The current approach is firmly established as being unique compared to the previous methods. Focused on AQ, as forced degradation for AQ and its impurities method was done for different parameters like oxidation, acid and base hydrolysis, thermal, photolytic degradations. Within this phase of work some unknown peaks were observed in the chromatogram and requires detailed analysis to identify the degradation products by using LCM-MS, NMR spectroscopy. The study on the effect of polymers on AS-AQ in taste masking formulations holds significant potential to enhance patient compliance. The future scope can be comprehensive research involving polymer selection, formulation development, and rigorous evaluation to achieve effective and safe taste masking solutions for AS-AQ.
1. ‘WHO Malaria’. Accessed: Jul. 31, 2022. [Online]. Available: https://www.who.int/health topics/malaria. 2. S. Görög, ‘Drug safety’, Journal of Pharmaceutical and Biomedical Analysis, vol. 48. pp. 247 253, 2008. 3. L. Catherine, K. Tina, and K. Jean-René, ‘The initial pharmaceutical development of an artesunate/amodiaquine oral formulation’, Malar J, vol. 10, p. 142, 2011. 4. ‘Artesunate: DrugBank Online’. Accessed: Jul. 31, 2022. [Online]. Available: https://go.drugbank.com/drugs/DB09274 5. ‘Amodiaquine: DrugBank Online’. Accessed: Jul. 31, 2022. [Online]. Available: https://go.drugbank.com/drugs/DB00613 6. A. Nair et al., ‘Biowaiver monographs for immediate release solid oral dosage forms: Amodiaquine hydrochloride’, Journal of Pharmaceutical Sciences, vol. 101, no. 12. John Wiley and Sons Inc., pp. 4390–4401, 2012. 7. Sullivan David J, Gluzman Ilya Y, Russell David G, and Goldberg Daniel E, ‘On the molecular mechanism of chloroquine’s antimalarial action’, Proceedings of the National Academy of Sciences, vol. 93, pp. 11865–11870, 1996. 8. N. Beer, A. S. Ali, G. Rotllant, and A. K. Abass, ‘Adherence to artesunate-amodiaquine combination therapy for uncomplicated malaria in children in Zanzibar, Tanzania’, Tropical Medicine and International Health, vol. 14, no. 7, pp. 766–774, Jul. 2009. 9. S. Ahuja, American Chemical Society. Division of Analytical Chemistry., and Pa. ) American Chemical Society. Meeting (188th : 1984 : Philadelphia, Chromatography and separation chemistry, vol. 6. American Chemical Society, 1986. Klaus Unger, ‘Introduction to High Performance Liquid Chromatography’. Accessed: Sep. 22, 2022. [Online]. Available: https://www.immun.lth.se/fileadmin/_migrated/content_uploads/L1L2HPLCintro_01.pdf
Publication Date
6/15/2026
Peer Review Type
Double-Blind Peer Review
Review Rounds: 2
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