Assay of Tretinoin using Safranine-O as a Chromogenic Reagent in Bulk and Dosage Forms

Year 2023, Volume: 10 Issue: 1, 139 - 146, 28.02.2023

Thuttagunta Manıkya Sastry , Venkata Nagalakshmi Kilana , Rama Krishna Karipeddi

https://doi.org/10.18596/jotcsa.1176621

Abstract

A new, economical and accurate analytical technique was developed for the assay of tretinoin (TTN) in bulk and formulations. While developing the method, it was found that the reaction was carried out due to the formation of ion-pair association complex involving the carboxyl group in the side chain of the TTN with safranine-O. The colored species formined was stable up to 60 minutes. The optical density of color species was measured at 520 nm. All the variables were optimized. The linearity range lies for the developed method within the concentration ranges of 2-10 μg mL-1.The linear correlation coefficient (r) and molar absorptivity (ϵmax)values were found as 0.9999 and 1.66 x 104 L mol–1cm–1. Percentage recoveries were found from 99.2 ± 1.8 to 100.2 ± 0.7.The method was validated as per ICH guidelines.

Keywords

Bioactive compounds, tretinoin, safranine- O (SFN-O), Ion-pair association complex, spectrophotometry., safranine-O(SFN-O)

Project Number

N/A

Thanks

The authors (Dr. T. Manikya Sastry and Dr.K. V. Nagalakshmi) are grateful to the organisation, GVPCOE (A) for their encouragement and support.

References

• 1. Fu LW, Vender RB. Newer approach in topical combination therapy for acne. Skin Therapy let. 2011;16(9):3-6.
• 2. Platzer DJ, White BA. Development and validation of a gradient HPLC method for the determination of clindamycin and related compounds in a novel tablet formulation. J Pharm Biomed Anal. 2006;41:84-88.
• 3. Tashtoush BM, Jacobson EL, Jacobson MK. A rapid HPLC method for simultaneous de-termination of tretinoin and isotretinoin in dermatological formulations. J Pharm Biomed Anal. 2007;43(3):859-864.
• 4. Fawzia I, Mohie KSE , El-Deen AK, and Kuniyoshi S. A New HPLC-DAD Method for the Concurrent Determination of Hydroquinone, Hydrocortisone Acetate and Tretinoin in Different Pharmaceuticals for Melasma Treatment. Journal of Chromatographic Science. 2019;57(6):495–501.
• 5. Abdelghani M, Mohamed SB. Simplified HPLC method for simultaneous determination of erythromycin and tretinoin in topical gel form. Sep Sci plus. 2020;1–8.
• 6. Sadaf S, Shahid H , Mohsin J, Ali R, Shahid I,Hamad A, Samar OA, Eslam B, HamoudH. Somaily, Rami AP, EmanA and Abd-E F. Simultaneous HPLC Determination of Clindamycin Phosphate, Tretinoin, and Preservatives in Gel Dosage Form Using a Novel Stability-Indicating Method. Inorganics.2022; 10(10):1-15.
• 7. Yuenong RY, Eden B, Richard B, Robert H, Barry H. Simultaneous determination of tretinoin and clindamycin phosphate and their degradation products in topical formulations by reverse phase HPLC. J Sep Sci. 2004;27:71-77.
• 8. Vaidya V, Baing MM, Joshi SS. Reverse phase high performance liquid chromatographic determination of tretinoin in bulk material, Indian Drugs. 2005; 42(1):42-45.
• 9. Sheliya K, Shah K, Kapupara P. Development and validation of analytical method for simultaneous estimation of mometasonefuroate, hydroquinone and tretinoin in topical formulation by RP-HPLC. J Chem Pharm Res. 2014: 6(4):934-940.
• 10. Vasanthi R, Rajitha N, Raja MA, Shrisha V, Banji D, Kumar DS. Analytical method development and validation of Isotretinoin in tablet dosage formulation. Asian J Pharm Anal Med Chem. 2015;3(3):145-153.
• 11. Ashish A, Manoj S ,Reverse-phase High-performance Liquid Chromatography Estimation of Methotrexate and Tretinoin in Bulk and Pharmaceutical Dosage Forms. International Journal of Pharmaceutical & Biological Archives 2019; 10(2):146-153.
• 12. Jamel MKA, Gagy AA. Development and validation of analytical spectrophotometric and RP-HPC methods for the simultaneous estimation of hydroquinone, hydrocortisone and tretinoin ternary mixture in topical formulation. International journal of pharmacy and pharmaceutical sciences.2019;11(11):10-16.
• 13. His SL, Surman P and Al-Kassas R. Development of a stability-indicating UPLC method for determination of isotretinoin in bulk drug. Pharmaceutical Development and Technology, 2018; 24 (2):189-198.
• 14. Dileusa DO, Diego FDA, Edilene GDO, Ruy CRB. Liquid chromatography method to assay tretinoin in skin layers: validation and application in skin penetration/retention studies. Heliyon. 2020;6:e03098.
• 15. Martins LE, Danielle G, Almeida DA, Nelson R, Antoniosi F. Development of a gas chromatography method for the determination of isotretinoin and its degradation prod-ucts in pharmaceuticals. J Pharm Biomed Anal.2005;38:678–685.
• 16. Slade HB, Shroot B, Feldman SR, Cargill DI, Stanfield J. Reappraising the phototoxicity of tretinoin: a report of four controlled clinical trials. Photodermatology, Photoimmunology&Photomedicine. 2009;25(3):146–152.
• 17. Maryam B, Ali YF, Jahanbakhsh G, Mohammad M, Ahari M, Nahid S, Mohammad Taghi B, Simultaneous spectrophotometric determination of minoxidil and tretinoin by the H-point standard addition method and partial least squares. Chem pap. 2009;63(3):336–344.
• 18. Patel P, Kabra P, Kimbahune R, Urmila GH. Quantitative estimation of isotretinoin (13-cis retinoic acid) in bulk and formulation by UV-visible spectrophotometry. Res J Pharm BiolChem Sci. 2011;2(1):167-172.
• 19. Pankti D, Kusum M, Mehul P. Development and validation of UV-visible spectrophotomet-ric method for simultaneous estimation of momentasonefuroate, hydroquinone and tret-inoin from their pharmaceutical dosage form. Int J Pharm Sci Rev Res. 2013;21(1): 296-300.
• 20. Zayed MA and Abdel-Basset MH. Spectrophotometric Micro determination of Tretinoin, Isotretinoin using Iodine and Tazarotene Micro determination Via Reaction with Rose-Bengal Reagent. Egypt. J. Chem. 61(1);2018:143 – 153.
• 21. Suraj D, Lobsang TK , Hauzel L, Laldinchhana, Sabir H. Development and validation of UV-spectrophotometric method for the determination of tretinoin. Journal of Xi’an Shiyou University. 2022;18(9):547-553.
• 22. Kiran D, Deepak N, Arvind N. Simultaneous UV spectrophotometric valuation of isotretinoin& their promoted drug. Int. J. Pharm. Sci. Rev. Res. 2018;49(1):82-85.
• 23. Barazandeh TM, Namadchian M, Fadaye VS, Souri E. Derivative spectrophotometric method for simultaneous determination of clindamycin phosphate and tretinoin in pharmaceutical dosage forms. DARU. 2013;21(1): 2-7.
• 24. Mahrous MS, Abdel-Khalek MM, Beltagy YA. Simultaneous Quantitation of Minoxidil and Tretinoin in Magistral and Pharmaceutical Preparations by First Derivative Spectrophotometry. Anal lett. 2006;25(9):1673-1686.
• 25. Nazira S and Abdulkader S. Development and validation of derivative UV spectroscopic method for simultaneous estimation of nicotinamide and tretinoin in their binary mixtures and pharmaceutical preparations. Sarkis and Sawan BMC Chemistry. 2022;16(15):1-11.
• 26. Massart DL, Vandeginste BGM, Doming S N, Michotte Y, Kaufman L. Chemometrics, A text Book, Amsterdam: Elsevier. 1988;293; 80.
• 27. ICH Harmonized Tripartite Guideline; International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Text and Methodology on Validation of Analytical Procedures, Q2, (R1); 2005.