ONE STEP QUANTIFICATION ANALYTICAL METHOD AND CHARACTERIZATION OF VALSARTAN BY LC-MS


S. Udhayavani, V. Girija Sastry, R. Govinda Rajan, V. Ramya Krishna, J. K. D. Tejaswi

Abstract


Objective: To develop precise LC-MS method for the estimation of valsartan impurities and perform validation as per ICH guidelines.

Methods: Valsartan (VLN) and its degradation products were analyzed by reverse phase high-performance liquid chromatography (RP-HPLC) using mobile phase water: acetonitrile: glacial acetic acid: phosphate buffer in the ratio of 500:500:1:0.5 v/v/v/v at 225 nm using column nucleosil C18, 125 ×4.0 mm, 5 µm. VLN sample (VLN SPL) thus obtained an unknown major impurity (UIMP) of 0.5 % at 0.38 retention time ratio (RRt) and purity of VLN was found to be 98.70 % respectively.

Results: Estimation of VLN SPL total unknown impurities was found to be 1.3% by RP-HPLC. In similarly by liquid chromatography mass spectroscopy (LC-MS) a typical chromatogram of valsartan (VLN) at Rt 9.03 min and UIMP at Rt 3.3 min were recorded at a total run time of 23 min. Assay of VLN SPL was validated as per international council for harmonization (ICH) guidelines. Average % recovery was found to be 100.04 % for VLN SPL.

Conclusion: The proposed work clearly indicates that the method can be easily adapted for the routine one step estimation of VLN active pharmaceutical ingredient (API).


Keywords


Valsartan, Acetonitrile, Methanol, LC-MS, Mobile Phase, Impurity

| PDF | HTML |

References


Nadeem S. Pharmacological and pharmaceutical profile of valsartan: a review. J Appl Pharm Sci 2011;4:12-9.

Ulrich B. A high-throughput process for the synthesis of valsartan. Int J Res Pharm Chem 2007;11:892–8.

N Rama Rao. Pharmaceutical impurities: an overview. Ind J Pharm Edu Res 2010;3:301-10.

S Lakshmana Prabu . Impurities and its importance in pharmacy. Int J Pharm Sci Rev Res 2010;2:66-71.

Kena H Patel. Simultaneous estimation of sacubitril and valsartan in the synthetic mixture by an RP-HPLC method. J Pharm Sci Bio Sci Res 2016;6:262-9.

LRD Bhavani. Method development and validation of HPLC for determination of levetiracetan and valsartan in their formulations. Res Rev J Pharm Anal 2015;2:42-56.

Ch Krishnaiah. Stability-indicating UPLC method for determination of valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms. J Pharm Biomed Anal 2010;3:483-9.

S Senthil Kumar. A validated gradient stability-indicating LC method for the analysis of valsartan in pharmaceutical dosage form. Int J Pharm Sci 2016;5:128-33.

Mittal A. Design of experiment based optimized RP-HPLC method for simultaneous estimation of amlodipine and valsartan in bulk and tablet formulations. Austin J Anal Pharm Chem 2015;6:1-6.

Subhajit G. RP-HPLC method for estimation of valsartan in solid oral dosage forms. J Pharm Sci Tech 2014;6:88-91.

Sridevi Ramachandran. Stability-indicating HPLC method for simultaneous determination of valsartan and ezetimibe in pharmaceuticals. Trop J Pharm Res 2014;5:809-17.

Tripti Sharma. Development and validation of a stability indicating RP-HPLC method for the determination of valsartan. Int J Pharm Sci 2015;7:57-61.

Sunil Pai. A simple reverse phase-high-performance liquid chromatography method development and validation of valsartan in bulk and it’s tablet dosage form. Asian J Pharm Clin Res 2017;6:333-7.




About this article

Title

ONE STEP QUANTIFICATION ANALYTICAL METHOD AND CHARACTERIZATION OF VALSARTAN BY LC-MS

Keywords

Valsartan, Acetonitrile, Methanol, LC-MS, Mobile Phase, Impurity

DOI

10.22159/ijap.2018v10i3.25254

Date

08-05-2018

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 10, Issue 3 (May-Jun), 2018 Page: 108-111

Online ISSN

0975-7058

Authors & Affiliations

S. Udhayavani
Department of Pharmaceutical Sciences, College of Pharmacy, Andhra University, Visakhapatnam, Andhra Pradesh, India
India

V. Girija Sastry
Department of Pharmaceutical Sciences, College of Pharmacy, Andhra University, Visakhapatnam, Andhra Pradesh, India

R. Govinda Rajan
Department of Pharmaceutical Chemistry, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh, India

V. Ramya Krishna
Department of Pharmaceutical Chemistry, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh, India

J. K. D. Tejaswi
Department of Pharmaceutical Chemistry, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh, India


Refbacks

  • There are currently no refbacks.