Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method

Pulusu, V.; Kommarajula, P.

Growing Science » Current Chemistry Letters » Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method

Journals

CCL Volumes

Volume 1 (23)
- Issue 1 (7)
- Issue 2 (5)
- Issue 3 (6)
- Issue 4 (5)

Volume 2 (26)
- Issue 1 (7)
- Issue 2 (6)
- Issue 3 (6)
- Issue 4 (7)

Volume 3 (30)
- Issue 1 (7)
- Issue 2 (10)
- Issue 3 (8)
- Issue 4 (5)

Volume 4 (21)
- Issue 1 (5)
- Issue 2 (5)
- Issue 3 (6)
- Issue 4 (5)

Volume 5 (20)
- Issue 1 (5)
- Issue 2 (5)
- Issue 3 (5)
- Issue 4 (5)

Volume 6 (20)
- Issue 1 (5)
- Issue 2 (5)
- Issue 3 (5)
- Issue 4 (5)

Volume 7 (15)
- Issue 1 (4)
- Issue 2 (4)
- Issue 3 (4)
- Issue 4 (3)

Volume 8 (20)
- Issue 1 (5)
- Issue 2 (5)
- Issue 3 (5)
- Issue 4 (5)

Volume 9 (20)
- Issue 1 (5)
- Issue 2 (5)
- Issue 3 (5)
- Issue 4 (5)

Volume 10 (43)
- Issue 1 (5)
- Issue 2 (7)
- Issue 3 (17)
- Issue 4 (14)

Volume 11 (43)
- Issue 1 (14)
- Issue 2 (11)
- Issue 3 (10)
- Issue 4 (8)

Volume 12 (78)
- Issue 1 (21)
- Issue 2 (22)
- Issue 3 (20)
- Issue 4 (15)

Volume 13 (68)
- Issue 1 (23)
- Issue 2 (17)
- Issue 3 (16)
- Issue 4 (12)

Volume 14 (20)
- Issue 1 (20)

Countries

Current Chemistry Letters

ISSN 1927-730x (Online) - ISSN 1927-7296 (Print) Quarterly Publication Volume 11 Issue 2 pp. 237-244 , 2022

Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method Pages 237-244 Download PDF

Authors: Veera Shakar Pulusu, Parasharamulu Kommarajula

DOI: 10.5267/j.ccl.2021.11.004

Keywords: Flibanserin, RP-HPLC, Development, Validation, ICH Guidelines

Abstract: Flibanserin (Addyi) is a medication used to treat women who have not gone through menopause who have low sexual desire. Specific and simple stability indicating method was developed and validated by high-performance liquid chromatography (RP-HPLC) for the determination of Flibanserin. Separation was carried out by using a mobile phase consisting of 0.01M Potassium phosphate monohydrate buffer (KH₂PO₄) pH 3.50 buffer: Acetonitrile in the ratio of 60:40. The column used was Agilent C18, (150×4.6) mm, 5µm with a flow rate of 1.0ml/min and temperature at 30°C. The detection was carried out at 248 nm and Flibanserin was eluted at around 2.8min. This method was validated as per ICH guidelines and validation included specificity, precision, linearity, accuracy, forced degradation, and robustness. Forced degradation was conducted under the conditions of hydrolysis, oxidation, thermal, acid, base, and peroxide hydrolysis. The calibration curve was linear over the concentration range from 20 to 200µg/mL and the coefficient of determination (r²) was observed as 0.9998. The precision and accuracy of the method were within the acceptable range. The results of this study showed that the validated method is simple and accurate, which confirmed that the method is suitable for the determination of Flibanserin.

How to cite this paper

 Pulusu, V & Kommarajula, P. (2022). Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method.Current Chemistry Letters, 11(2), 237-244.

Refrences

1. Center for drug evaluation and research (2015) Application number: 022526Orig1s000. FDA Chemistry reviews., NDA 22526.
2. Long He, Wenting You, Sa Wang, Tian Jiang, Caiming Chen. (2019) A rapid and sensitive UPLC-MS/MS method for the determination of Flibanserin in rat plasma: application to a pharmacokinetic study. BMC Chemistry, 13(1) 111.
3. Maha A. Sultan, Rasha Th. EL-Eryan, Ali K. Attia, Mona J. Eissa. (2019) Development and validation of liquid chromatography-electrospray-tandem mass spectrometry method for determination of Flibanserin in human plasma: Application to pharmacokinetic study on healthy female volunteers. Biomedical Chromatography, 33(8) e4545.
4. Manish Kumar Sharma, Rajeshwari Rathod, Pinaki Sengupta. (2020) Mass Spectrometry-Based Rapid Quantitative Bioanalysis of Flibanserin: Pharmacokinetic and Brain Tissue Distribution Study in Female Rats. Journal of Analytical Toxicology, 44(6) 559-569.
5. Millheiser L, Clayton AH, Parish SJ, Kingsberg SA, Kim NN, Simon JA. (2019) Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. The Journal of Sexual Medicine, 7(4) 418-424.
6. Muzaffar Iqbal, Essam Ezzeldin, Naser L Rezk, Amal A Bajrai, Khalid A AL-Rashood. (2018) A validated UPLC-MS/MS method for Flibanserin in plasma and its pharmacokinetic interaction with bosentan in rats. Future Science-Bioanalysis, 10(14) 1087-1097.
7. Pinaki Sengupta, Manish Kumar Sharma, Ravi P. Shah. (2020) Amalgamation of stress degradation and metabolite profiling in rat urine and feces for characterization of oxidative metabolites of Flibanserin using UHPLC-Q-TOF-MS/MS, H/D exchange and NMR technique. Journal of Chromatography B, 15(1139) 121993.
8. Rasha Ahmed, Inas Abdallah. (2020) Development and Greenness Evaluation of Spectrofluorometric Methods for Flibanserin Determination in Dosage Form and Human Urine Samples. Molecules, 25(21) 4932.
9. Simson JA, Clayton AH, Parish SJ, Apfel SC, Millheiser L. (2020) Effects of Alcohol Administered with Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. The Journal of Sexual Medicine, 17(1) 83-93.
10. Kowmudi Gullapalli, K. Anbu, M. Udhaya Prakash, P. Durai Rajan, P. Ramalingam, N. Krishnaveni. (2019) A novel LC-ESI-MS/MS Method for the Quantification of Flibanserin in Bulk and Pharmaceutical Formulations. Royal Society of Chemistry-Conference on Drug Design and Discovery Technologies, 330-339.
11. Manish kumar sharma. (2019) QBD Driven stability-indicating RP-HPLC assay method for Flibanserin: Development, Validation and characterization of major degradants by LC/QTOF-MS/MS. Annals of Clinical Trials and Vaccines Research, 2(1) 1-2.
12. Rasha M. Ahmed, Inas A. Abdallah. (2020) Determination of Flibanserin in the presence of confirmed degradation products by a third derivative emission spectrofluorometric method: Application to pharmaceutical formulation. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 225, 117491.
13. Yuanyang WU, Ren WANG, Minghao ZHOU, Qiaoyuan CHENG. (2017) Detection of Avanfil and Flibanserin in Health Food by HPLC-MS/MS. Herald of medicine. 36(7) 783-785.
14. Chew Yik-Ling, Lee Hon-Kent, Bontha Venkata Subrahmanya Lokesh. (2020) New stability indicating method for estimation of purity of Flibanserin active pharmaceutical ingredient, Indian Drugs, 57(04).
15. Sharma P, Dahiya M, Wakode S, Rani R. (2020) HPLC Method Development and Validation: For simultaneous determination of Flibanserin and Caffeine. Open Access Journal of Pharmaceutical Research, 4(3) 000213.
16. A guide to analytical method validation. (2006) Waters corporation.
17. Center for drug evaluation and research. Reviewer guidance. (1994) Validation of chromatographic methods.
18. Hildegard Brummer (2011) How to approach a forced degradation study. SGS life science services., N0 31.