Tejasvini Neve, Vijaya Vichare, Manasi Rokade, S.N. Dhole
Tejasvini Neve*, Vijaya Vichare, Manasi Rokade, S.N. Dhole
PES Modern College of Pharmacy (For Ladies) Moshi, Savitribai Phule University, Pune, Maharashtra, India.
Volume - 13,
Issue - 3,
Year - 2023
A simple, rapid and eco-friendly UV spectroscopic method was developed for the estimation of Adapalene along with Phenoxyethanol for laboratory purpose. Bulk drug and marketed formulation both are analyzed and validated by this method. Tetrahydrofuran was selected for the solubility of Adapalene and Phenoxyethanol as per solubility profile. Wavelength selected for Adapalene and Phenoxyethanol was 325nm and 269nm respectively. In the proposed method, adapalene and phenoxyethanol follows linearity in the concentration range 1-5µg/mL and 2.5-12.5µg/mL with a correlation coefficient 0.999 and 0.998 respectively. Proposed method was statistically validated as per ICH guidelines and by recovery studies. The standard deviation was found to be less than 2, which showed excellent precision and accuracy.
Cite this article:
Tejasvini Neve, Vijaya Vichare, Manasi Rokade, S.N. Dhole. Simultaneous Estimation of Adapalene from Marketed Gel Formulation along with the Preservative Phenoxyethanol by UV- Visible Spectroscopy. Asian Journal of Pharmaceutical Research. 2023; 13(3):206-9. doi: 10.52711/2231-5691.2023.00039
Tejasvini Neve, Vijaya Vichare, Manasi Rokade, S.N. Dhole. Simultaneous Estimation of Adapalene from Marketed Gel Formulation along with the Preservative Phenoxyethanol by UV- Visible Spectroscopy. Asian Journal of Pharmaceutical Research. 2023; 13(3):206-9. doi: 10.52711/2231-5691.2023.00039 Available on: https://asianjpr.com/AbstractView.aspx?PID=2023-13-3-13
1. Available onhttps://pubchem.ncbi.nlm.nih.gov/compound/adapalene.
2. Piskin S and Uzunali E. A review of the use of adapalene for the treatment of acne vulgaris. Therapeutics and Clinical Risk Management. 2007; 3(4): 621–624.
3. Kadam TV., Waghmare SS., Darekar AB., Saudagar RB. An Overview: Acne Vulgaris.Res. J. Pharm. Dosage Form. and Tech. 2015; 7(2):156-160.
4. European Pharmacopoeia, Published by Council of Europe, Strasbourg Cedex, 2010; 7(2): pp-1324–26.
5. Tripathi KD. Essentials of Medical Pharmacology. 6th Edition. Jaypee Brothers Medical Publishers, Pvt. Ltd. 2008; pp- 853.
6. Bajaj A, John C, Tripathi RM, Choudhury J. Validated RP-capillary HPLC-DAD method for Simultaneous analysis of some Paraben Preservatives in Pharmaceutical and Cosmetics/Personal care Formulations. Asian J. Pharm. Ana. 2017; 7(4): 229-234. doi: 10.5958/2231-5675.2017.00037.0
7. Modi PB. Novel Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Clindamycin Phosphate and Adapalene along with Preservatives in Topical Gel Formulations. Scientia Pharmaceutica. 2014; 82(4): 799–813. doi:10.3797/scipharm.1404-01.
8. Tolba MM and EI-Gamal RM. Determination of adapalene in gel formulation by conventional and derivative synchronous fluorimetric approaches. Application to stability studies and in vitro diffusion test. Chemistry Central Journal. 2016 May 28; 10:33. doi: https://doi.org/10.1186/s13065-016-0181-0.
9. Adhikari L, Sarbeswar J, Sanib S, Moitra SK, Murthy PN. Derivative Spectrophotometric Determination of Adapalene in its Bulk and Pharmaceutical Dosage Form. Asian Journal of Chemistry. 2012; 24(3):1094-1096. Available on https://asianjournalofchemistry.co.in/user/journal/viewarticle.aspx?ArticleID=24_3_33.
10. Thummar K, Tilva K, Dudhatra B. Validated stability-indicating HPTLC method for the estimation of adapalene in drugs and the LC–MS identification of its degradation products. Journal of Planar Chromatography – Modern TLC. 2020; 33:371–380. doi: https://doi.org/10.1007/s00764-020-00042-z.
11. Doyle RM, Kline J, Thermo Scientific Inc.: LC-MS-MS quantitative analysis of 12 Retinoids, derivatives and metabolites in serum for clinical research use. Thermo Fisher Scientific Inc. 2017. Available on https://assets.thermofisher.com/TFS-Assets/CMD/posters/PO-65009-LC-MS-VitA-Serum-ASMS2017-PO65009-EN.pdf
12. Mailvelan R, Selvamani P, Rameshkumar T, et al. HPLC method development and validation for the estimation of Adapalene in pharmaceutical formulations. Asian J Pharm Anal Med Chem. 2013; 1(3):166–71. doi: 10.19080/GJPPS.2018.04.555639
13. Kumara G, Patrudub TB, Raoa MVB and Rao TM. A Novel Method Development and Validation for Related Substances of Adapalene in Bulk Drug Product by HPLC.Research J. Pharm. and Tech. December 2016; 9(12): 2234-2240. doi: 10.5958/0974-360X.2016.00451.0
14. Mudasir M, Tabassum N. Ali J, et al. Estimation of adapalene through isocratic HPLC method in pharmaceutical gel formulations: Analytical Chemistry an Indian Journal. 2008; 7(11):801-806. Available on https://www.semanticscholar.org/paper/Estimation-of-adapalene-through-isocratic-HPLC-in-M.Mudasir-Tabassum/130559dcbd68e6e95ae181ab3ddadcd62702840d.
15. Martins LA, Meneghini LZ, Junqueira CA, et al. A simple HPLC-DAD method for determination of Adapalene in topical gel formulation. J Chromatogr Sci. 2011; 49(10):796–800. doi: https://doi.org/10.1093/chrsci/49.10.796
16. Yi-cheng Chen, Pi-ju Tsai, Yaw-bin Huang, et al. Optimization and validation of high-performance chromatographic condition for simultaneous determination of Adapalene and benzoyl peroxide by response surface methodology. PLoS One. 2015; 10(3):1–9. doi: https://doi.org/10.1371/journal.pone.0120171
17. Khatri RH, Patel RB and Patel MR. A new RP-HPLC method for estimation of clindamycin and Adapalene in gel formulation: development and validation consideration. The Thai Journal of Pharma Sciences. 2014; 38(1): 1-56. Available on https://www.thaiscience.info/journals/Article/TJPS/10963054.pdf
18. Sahare P, Nayak A, Jain A, et al. Development of Validated Analytical Methods and Stability Indicating studies for Pharmaceutical Formulation.Asian J. Pharm. Ana. 2021; 11(1):29-37. doi: 10.5958/2231-5675.2021.00006.5
19. Kumar N, Kaur K, Kumar R, Biswal SS, et al. Analytical Method Development and Validation for the Estimation of Miconazole Nitrate in Bulk and Marketed Topical Formulation. Research J. Pharm. and Tech. 2019; 12(10):4999-5003. doi: 10.5958/0974-360X.2019.00866.7
20. Available onhttps://www.netmeds.com/prescriptions/adapen-gel-15gm.
21. Priyanka R Patil, Sachin U Rakesh, Pandurang N Dhabale, Kishor B Burade. Simultaneous Estimation of Ramipril and Amlodipine by UV Spectrophotometric Method. Research J. Pharm. and Tech. 2009; 2(2): 304-307. Available on: https://rjptonline.org/AbstractView.aspx?PID=2009-2-2-63
22. Amitkumar J. Vyas, Shalini Anilkumar Jha, A.B. Patel, AI Patel, S. R. Shah, D. B. Sheth. Review on Simultaneous Equation Method (Vierodt’s Method). Asian Journal of Pharmaceutical Analysis. 2022; 12(2):149-6. doi: 10.52711/2231-5675.2022.00026
23. Tripathy S. Pharmaceutical Validation: A Quality Maintaining Tool for Pharmaceutical Industry. Asian Journal of Pharmaceutical Research. 2020; 10(4):307-311. doi: 10.5958/2231-5691.2020.00052.0.
24. Shingote V, Mankar SD, Dighe SB. A Review Article on Analytical Methods Development and Validation. Research Journal of Science and Technology. 2022; 14(1):77-3. doi: 10.52711/2349-2988.2022.00012
25. Ghagare P, Patil A, Deshmane B, et al. Review on Pharmaceutical Validation. Res. J. Pharma. Dosage Forms and Tech.2020; 12(1): 17-26.
26. ICH, Q2 (R1) validation of analytical procedures: text and methodology, International Conference on Harmonization; Nov 2005.