METHOD DEVELOPMENT AND VALIDATION OF EPROSARTAN MESYLATE AND ITS IMPURITIES USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY
Objective: Our main objective is to develop an accurate and precise RP-HPLC method for the determination of Eprosartan Mesylate and its impurities.
Methods: A Develosil ODS UG-5; (150 Ã— 4.6) mm; 5 Âµm column was used for the Separation of drugs by a mobile phase consisting of Buffer and Acetonitrile mixture in the gradient proportion. The flow rate maintained was 0.8 ml/min and the wavelength used for detection was 235 nm.
Results: The linearity was observed in the range of 0.025-50Âµg/ml of spiked impurities in Eprosartan Mesylate, impurity 1 and impurity 2 with a correlation coefficient of 0.99927, 0.99910 and 0.99934 respectively. The mean percentage recoveries for LOQ, 50%, 80%, 100%, 150% and 200% accuracy were found to be 101.5Â±1.51, 107.0Â±1.7, 104.6Â±0.4, 102.8Â±0.36, 101.7Â±0.26 and 101.3Â±0.15 respectively for impurities in Eprosartan Mesylate, impurity 1 and impurity 2. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation.Conclusion: The developed method is uncomplicated, accurate, sensitive and precise for the determination of related substances in the Eprosartan Mesylate. The satisfying % recoveries and low % RSD Values confirmed the suitability of the developed method for the usual analysis of Eprosartan mesylate in pharmaceuticals.
2. http://www.tlcstandards.com/ProdDetail.aspx?ID=E-1510andname=EPROSARTAN. [Last accessed on 01 Jan 2016].
3. www.usp.org/sites/default/files/usp_pdf/EN/USPNF/./m5875.pdf. [Last accessed on 01 Jan 2016].
4. http://tlcpharma.com/productdetails.php?subcatid=179. [Last accessed on 01 Jan 2016].
5. Nandakumar K, Santhi DV, Jothieswari D, Subathrai R, Vetrichelvan T. Development and validation of a UV spectrophotometric method for the simultaneous estimation of eprosartan mesylate and hydrochlorothiazide in bulk and formulations. Indian J Pharm Sci 2011;73:569-72.
6. K Veerreddy, Teja kumar P, Sunil K Dandeti, Bolli Sandeep. Simultaneous UV spectroscopic analysis of eprosartan mesylate and hydrochlorothiazide tablets by absorption ratio method. J Pharm Res 2012;5:4371-4.
7. Anandakumar K, Vijaya Santhi D, Jayamariappan M. Development and validation of eprosartan mesylate and hydro-chlorothiazide in pure and in fixed-dose combination by UV spectrophotometry. Int J Pharm Indian Res 2011;1:22-7.
8. Rewar S, Bansal BK, Singh CJ, Sharma AK. Approach for quantitative estimation of eprosartan mesylate by UV spectrophotometer. Int J Res Dev Pharm Life Sci 2014;3:1300-3.
9. Abdul Ahad, Abdullah Mohammed Al-Mohizea, Abdulmohsen Abdullah Al-Saleh, Abdullah Sulaman Alwabel, Abdulaziz Jaber Aqel, Khalid Mahdi Al-Qahtani, et al. Validation of a rapid and sensitive HPLC-UV method for the quantification of eprosartan mesylate in bulk drug, teventen TM and ultra deformable lipid-based vesicular system. Curr Pharm Anal 2016;12:1-6.
10. Sitaram Cheekatla, Ravichandrababu Rupakula, Bommineni Narasimha Reddy, Musty Sharada. Determination and characterization of process impurities for Eprosartan Mesylate. J Pharm Res 2013;6:504-9.
11. Patel HU, Suhagia BN, Patel CN. Simultaneous analysis of eprosartan and hydrochlorothiazide in tablets by high-performance liquid chromatography. Pharm Methods 2011;2:143-7.
12. V Kiran Kumar, N Appala Raju, Jvln Seshagiri Rao, T Satyanarayana. The estimation of eprosartan mesylate in pharmaceutical dosage forms by RP-HPLC Orient. J Chem 2009;25:711-4.
13. Vineeta Khanvilkar. HPTLC method for determination of eprosartan mesylate in human plasma. Indo Am J Pharm Res 2013:3;10.
14. Ravi Piyushkumar Shah, Archana Sahu, Saranjit Singh. Identification and characterization of geometrical isomeric photodegradation product of eprosartan using LCâ€MS and LCâ€NMR. Eur J Chem 2011;2:152â€7.