Asian Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

A New Analytical Method Validation and Quantification of Olmesartan Medoxomil and its Related Impurities in Bulk Drug Product by HPLC.


Affiliations
1 Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
2 Department of Marine Living Resources, Andhra University, Visakhapatnam, Andhra Pradesh, India
     

   Subscribe/Renew Journal


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of olmesartan Medoxomil and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Zorbax Eclipse XDB-C8 column employing 00.1% H3PO4 in Water: Acetonitrile in the ratio of 50:50 (v/v) as mobile phase with gradient initially A:B:70:30 and followed as Time/A/B: 25/30/70; 30/30/70; 31/75/25 and runtime is 35 mins at flow rate 1.0 mL/min was chosen. All impurities were eluted within 18 minutes. The column temperature was maintained at 30oC and a detector wavelength of 225 nm was employed. The method was successfully validated by establishing Specificity, Linearity, Precision, Accuracy, Limit of detection and Limit of quantification.

Keywords

HPLC, Method Validation, Related Impurities, Olmesartan Medoxomil, LOQ, LOD.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Tapeesh Bharti, Rakhi Mishra, Chatrasal Singh Rajput, Richa Singhal. Analytical method development and validation of assay for Olmesartan Medoxomil in formulated product by reverse phase ultra performance liquid chromatography. European Journal of Biomedical and Pharmaceutical Sciences. 2016; 3(2): 215-222.

  • Kuldeep Singh, Anirbandeep Bose, Gurubasavaraja Swamy PM, Divakar Goli. Method development and validation of simultaneous analysis of Olmesartan Medoxomil and hydrochlorothiazide by UV and HPLC, their cross validation. World Journal of Pharmacy and Pharmaceutical Sciences. 2015; 4(7): 905-917.

  • Shailesh T. Prajapati, Hitesh H. Bulchandani, Dashrath M. Patel, Suresh K. Dumaniya, Chhaganbhai N. Patel. Formulation and Evaluation of Liquisolid Compacts for Olmesartan Medoxomil. Hindawi Publishing Corporation Journal of Drug Delivery. 2013; 2013: 1-9.

  • A.T. Hemke, M.V. Bhure, K.S. Chouhan, K.R. Gupta, S.G. Wadodkar. UV Spectrophotometric Determination of Hydrochlorothiazide and Olmesartan Medoxomil in Pharmaceutical Formulation. E-Journal of Chemistry. 2010; 7(4): 1156-1161.

  • Abdullah A Masud, Md. Mahfuzur Rahman, Moynul Hasan, Md. Kamal Hossain Ripon, Ahsanur Rahman Khan, Md. Rabiul Islam, Md. Raihan Sarkar. Validated Spectrophotometric Method for Estimation of Olmesartan Medoxomil in Pharmaceutical Formulation. International Journal of Pharmaceutical and Life Sciences. 2012; 1(3): 1-7.

  • Chimalakonda Kameswara Rao1, , Kakumani Kishore Kumar , Maddala Vijaya Laxmi, Polisetty Srinivasulu, Gutta Madhusudhan, Khagga Mukkanti, Koduri Sai Venkata Srinivas. Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil. American Journal of Analytical Chemistry. 2012;3:153-160.

  • G. Kumar, T.B. Patrudu, Tentu Nageswara Rao, M.V. Basaveswara Rao, A New Analytical Method Validation and Quantification of Benazepril and its Related Substance in bulk Drug Product by HPLC, Asian Journal of Pharmaceutical Analysis, 2017; 7(1): 1-5.

  • G. Kumar, T B. Patrudu, M.V. Basaveswara Rao and Tentu. Nageswara Rao, A Novel Method Development and Validation for Related Substances of Adapalene in Bulk Drug Product by HPLC, Research J. Pharm. and Tech 2016; 9(12):2234-2240.

  • G. Kumar, T. B. Patrudu, Tentu. Nageswara Rao, M. V. Basaveswara Rao, A new analytical HPLC method for cleaning validation of pantoprazole sodium bulk drug product, Indo American Journal of Pharmaceutical, Research.2016:6(10), 6584-6593.

  • International Conference on Harmonisation, Validation of Analytical Procedures. ICH Q2B. 1996.


Abstract Views: 284

PDF Views: 0




  • A New Analytical Method Validation and Quantification of Olmesartan Medoxomil and its Related Impurities in Bulk Drug Product by HPLC.

Abstract Views: 284  |  PDF Views: 0

Authors

Tentu Nageswara Rao
Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
A. Vijayalakshmi
Department of Marine Living Resources, Andhra University, Visakhapatnam, Andhra Pradesh, India
Karri Apparao
Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
N. Krishnarao
Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India

Abstract


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of olmesartan Medoxomil and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Zorbax Eclipse XDB-C8 column employing 00.1% H3PO4 in Water: Acetonitrile in the ratio of 50:50 (v/v) as mobile phase with gradient initially A:B:70:30 and followed as Time/A/B: 25/30/70; 30/30/70; 31/75/25 and runtime is 35 mins at flow rate 1.0 mL/min was chosen. All impurities were eluted within 18 minutes. The column temperature was maintained at 30oC and a detector wavelength of 225 nm was employed. The method was successfully validated by establishing Specificity, Linearity, Precision, Accuracy, Limit of detection and Limit of quantification.

Keywords


HPLC, Method Validation, Related Impurities, Olmesartan Medoxomil, LOQ, LOD.

References