Development And Validation of Rp-Uplc Method For Simultaneous Estimation Of Iloperidone And Idebenone In Sublingual Bilayer Tablets
DOI:
https://doi.org/10.53555/ejac.v20i1.1138Keywords:
RP-UPLC, Idebenone, Iloperidone, sub-lingual bilayer tablets, method development and validation.Abstract
Aim: Establishing and validating the stability indicating Reverse-Phase Ultra Performance Liquid Chromatography (RP-UPLC) technique for simultaneous measurement of Iloperidone and Idebenone in sublingual bilayer tablets is the main goal of this research work.
Methods: Acetonitrile as the mobile phase, 0.1% v/v orthophosphoric acid in water, a flow rate of 0.4 ml/min, and a detection wavelength of 240 nm were all necessary for the successful separation of Iloperidone and Idebenone utilizing an HSS column C18 (100 X 2.1 mm). According to ICH requirements, the stability of the active ingredients in mixed powder and sublingual bilayer tablets was evaluated under extreme circumstances such as heat degradation, peroxide oxidation, and acid-base hydrolysis.
Results and Discussion: Iloperidone and Idebenone are pharmaceutically significant combinations recommended in the treatment of numerous psychiatric and neurological conditions. Articulating these compounds into sublingual bilayer tablets enhances their bioavailability and efficacy. Therefore, an accurate and precise analytical method is imperative for their simultaneous estimation to ensure product quality and therapeutic effectiveness. Iloperidone and Idebenone had different retention times, with Iloperidone at 0.49 min and Idebenone at 0.93 min. The proposed method shows linear responses for Iloperidone (5–30 μg/mL) and Idebenone (2.5–15 μg/mL) within concentration ranges. The calculated limits for detecting and measuring Iloperidone were 0.22μg/mL & 0.47μg/mL, respectively, while for Idebenone they were 0.12μg/mL & 0.36μg/mL. All the validation parameters for the method confirmed according to the ICH Q2 acceptance limits. Significant resolution between Iloperidone, Idebenone, and their degradation products has been noted in the methodology's stability aspect.
Conclusion: The proposed RP-UPLC method demonstrated high sensitivity, precision, and stability indication, making it a potentially viable technique for the simultaneous estimation of Iloperidone and Idebenone in sublingual bilayer tablets.
References
Vij I, Pathania A. An Overview-Advance in Chromatographic Techniques in Photochemistry. EDP Sciences. 2023;391:01038.
Lorenc W, Kruszka D, Kachlicki P, Kozłowska J, Barałkiewicz D. Arsenic species and their transformation pathways in marine plants. The usefulness of advanced hyphenated techniques HPLC/ICP-MS and UPLC/ESI-MS/MS in arsenic species analysis. Talanta. 2020;220:121384.
González-Burgos E, Fernández-Moriano C, Gómez-Serranillos MP. Current knowledge on Parmelia genus: Ecological interest, phytochemistry, biological activities, and therapeutic potential. Phytochemistry. 2019; 165:112051.
Parys W, Dołowy M, Pyka-Pająk A. Current strategies for studying the natural and synthetic bioactive compounds in food by chromatographic separation techniques. Processes. 2021; 9(7): 1100.
G TD. Novel Analytical Techniques used in Identification and Isolation of Impurities in Pharmaceuticals an Overview. J Pharm Sci Res. 2020; 12(1):37-42.
Gordillo R. Supercritical fluid chromatography hyphenated to mass spectrometry for metabolomics applications. J Sep Sci. 2021; 44(1):448-463.
Penmatsa VK, Kanakapura B, Nagaraju S. Development and validation of a stability-indicating RP-UPLC method for the determination of fluconazole in bulk drug and in pharmaceutical dosage forms. Pharmaceuticals. 2014;31: 32.
Ahmed S, Islam S, Ullah B, Biswas SK, Azad AS, Hossain S. A review article on pharmaceutical analysis of pharmaceutical industry according to pharmacopoeias. Orient J Chem. 2020; 36.
Coskun O. Separation techniques: Chromatography. North Clin Istanb. 2016; 3(2):156–160.
Landge SB, Jadhav SA, Vishwambar SP, Solanki PV, Bembalkar SR, Mathad VT. Development and validation of RP-UPLC method for the determination of Iloperidone, its related compounds and degradation products in bulk and dosage form. American Journal of Analytical Chemistry. 2014; 5(14):969.
Atila Karaca S, Uğur DY. Determination of Iloperidone in Pharmaceuticals by Validated High-Performance Liquid Chromatography. Analytical Letters. 2018; 51(1-2):24-32.
Gueven N, Ravishankar P, Eri R, Rybalka E. Idebenone: When an antioxidant is not an antioxidant. Redox Biol. 2021;38:101812.
Nohara Y, Suzuki J, Yamazaki Y, Kubo H. Determination of idebenone in plasma by HPLC with post-column fluorescence derivatization using 2-cyanoacetamide. Chem Pharm Bull. 2012;60(5):598 602.
Londhe V, Shirsat R. Formulation and characterization of fast-dissolving sublingual film of iloperidone using Box–Behnken design for enhancement of oral bioavailability. AAPS PharmSciTech. 2018; 19:1392-400.
Bhowmik D, Chiranjib B, Krishnakanth P, Chandira RM. Fast dissolving tablet: an overview. J Chem Pharm Res.2009;1(1):163–77.
Batinic B, Ristic I, Zugic M, Baldwin DS. Treatment of symptom clusters in schizophrenia, bipolar disorder and major depressive disorder with the dopamine D3/D2 preferring partial agonist cariprazine. Front Psychiatry. 2021;23(12):784370 4.
Citrome L, McEvoy JP, Todtenkopf MS, McDonnell D, Weiden PJ. A commentary on the efficacy of olanzapine for the treatment of schizophrenia: the past, present, and future. Neuropsychiatr Dis Treat. 2019; 15:2559–69.
Rafi S. A new validated method for the estimation of olanzapine and Samidorphan using high performance liquid chromatography and of its degradation. Biosci Biotechnol Res Commun. 2021;14(9):198–204.
Batinic B, Djokic V, Ivkovic M. Assessment of cognitive function, social disability and basic life skills in euthymic patients with bipolar disorder. Psychiatr Danub. 2021;33(3):320-327.
Green MF. Cognitive impairment and functional outcome in schizophrenia and bipolar disorder. J Clin Psychiatry. 2006; 67(10):e12.
ICH. Quality Guidelines ICH. https:// www. ich.org/ page/quality- guide lines. Accessed 18 Nov 2023.
Berrettini W. Evidence for shared susceptibility in bipolar disorder and schizophrenia. Am J Med Genet C Semin Med Genet. 2003; 123C (1):59–64.
Alam M, Jahan K. Informative review of layered technology of tablet-an emerging innovation in oral drug delivery system. EJPMR, 2023;10(12): 667-675.
P. BR, P JB. A Comprehensive Review on Technological Aspects in Bilayer Tablet Manufacturing. World Journal of Pharmaceutical Research. 2022; 11(3):1947–63.
S. R, T P. A Recent Review on Dual Release Bilayered Tablet. Critical Review in Pharmaceutical Sciences. 2016; 5(4):1–11.