STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF VILAZODONE HYDROCHLORIDE
Objective: The aim and objective of this study was to develop and validate Stability Indicating HPLC method for determination of Vilazodone Hydrochloride.
Methods: The method was carried out on a Phenomenex, C18 (250x4.6 mm, 5 Âµm) Column using a mixture of Acetonitrile: Water (50:50v/v), pH adjusted to 3.3 with Glacial Acetic Acid for separation. The flow rate was adjusted at 1 ml/min and Detection was carried out at 240 nm.
Results: The retention time of vilazodone hydrochloride was found to be 2.3 min. The calibration curve was found to be linear in the range 25-75Âµg/ml with a correlation coefficient (R2=0.996). The limit of detection and limit of quantitation were found to be 4.78Âµg/ml and 14.48Âµg/ml respectively. The % recovery of vilazodone hydrochloride was found to be in the range of 98.21Â±0.08 % to 99.07Â±0.64%. The proposed method was successfully applied for the estimation of vilazodone hydrochloride in marketed tablet formulation.
Vilazodone Hydrochloride was subjected to forced degradation under Acidic, Alkaline, Oxidation, Dry Heat and Photolytic degradation conditions. Vilazodone hydrochloride showed 3.12% degradation under acidic condition, 4.78% under alkaline condition, 7.8% under oxidation condition, 3.53% under dry heat condition and 4.9% under photolytic condition.
Acid degradation impurity was identified and characterised by LC-MS/MS was found to be 1-(4-Penten-1-yl) piperazine having molecular weight 154.253 (m/z 155.08) and Molecular Formula C9H18N2.Conclusion: A simple, precise, rapid and accurate Stability Indicating HPLC method has been developed and validated for the determination of Vilazodone Hydrochloride in presence of its degradation products as per the ICH Guidelines.
2. https://www.drugs.com/monograph/vilazodone-hydrochloride.html [Last accessed on 20 Dec 2017]
3. Reddy PB, Pramod N, Venkateshwararao P, Sudhakar babu AMS. Method development and validation for the assay of vilazodone in bulk and formulation by using RP-HPLC. Int J Biol Pharm Res 2012;3:789-95.
4. Gosh S, Venkatesh S, Ravikumar BVV. Development of stability indicating RP-HPLC method and validation for the estimation of vilazodone hydrochloride. Int J PharmTech Res 2015;7:204-11.
5. Ravishankar P, Gowthami S, Devanshu CH, Shrinivas Babu P, Reddy PV. A novel validated RP-HPLC method for the estimation of vilazodone in bulk and pharmaceutical dosage form. Am J PharmTech Res 2014;4:670-82.
6. Venkata SG, Devika GS, Salibai R, Hemalatha K. Determination of vilazodone in pharmaceutical formulations by HPLC method. J Global Trends Pharm Sci 2014;5:2261-64.
7. Thangabalan B, Lakshmi NR, Syedali Fathima SK, Manohar Babu S. UV Spectrophotometric estimation of Vilazodone in pure and tablet dosage form. Asian J Pharm Res 2015;5:126-7.
8. Damle MC, Agrawal AA. Development and validation of stability indicating HPTLC method for estimation of vilazodone hydrochloride. Int J Pharm Res Scholars 2015;4:262-8.
9. Kalariya PD, Talluri MVNK, Patel PN, Shrinivas R. Identification of hydrolytic and isomeric N-oxide degradants of vilazodone by online LC-ESI-MS/MS and APCI-MS. J Pharm Biomed Anal 2015;102:353-65.
10. Marwa F, Ramzia EB, Hanaa H, Tarek S. UPLC-MS/MS method for the determination of vilazodone in human plasma: application to a pharmaceutical study. J Diagnos Tech Biomed Anal 2015;3:118.
11. Sui W, Yang X, Yu W, Jin Yi, Luan X, Wang X, et al. A validated LC-MS/MS method for the rapid quantification of vilazodone in rat plasma: application to a pharmacokinetic study. J Pharm Biomed Anal 2014;98:228-34.
12. Kalariya PD, Talluri MVNK, Shrinivas R. Experimental design approach for selective separation of vilazodone HCl and its degradants by LC-PDA and characterization of major degradants by LC/QTOF-MS/MS. J Chromatogr 2014;17:1299-313.
13. Dedania ZR, Dedania RR, Sheth NR, Gajra B, Patel J. Development and validation of stability-indicating high performance liquid chromatography assay for aripiprazole in bulk drug substance. Asian J Pharm Biol Res 2011;1:123-8.
14. Dedania ZR, Dedania RR, Sheth NR. Stability indicating HPLC determination of quetiapine fumarate. Int J Pharm Sci Res 2013;4:2406-14.
15. Dedania ZR, Dedania RR, Sheth NR, Patel JB, Patel B. Stability indicating HPLC determination of risperidone in bulk drug and pharmaceutical formulations. Int J Anal Chem 2011:1-7. http://dx.doi.org/10.1155/2011/124917
16. ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2 (R1), International Conference on Harmonization, Geneva: Switzerland; 2005. p. 1-13.
17. Q1 R2: Stability Testing of New Drugs and products, International Conference on Harmonization of Technical Requirements For Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline; 2003. p. 1-18.