Journal of Pharmacy and Experimental Medicine

Research Article | Open Access

Volume 2021 - 2 | Article ID 184 | http://dx.doi.org/10.51521/JPEM.2021.2209

Forced Degradation Studies by HPTLC-MS Method for Estimation of Azilsartan Kamedoxomil in Pharmaceutical Dosage Form

Academic Editor: Mari Uyeda

  • Received 2021-08-02
  • Revised 2021-08-14
  • Accepted 2021-09-23
  • Published 2021-09-01

Yogesh Zambare, Shraddha Shinde, Vaibhav Gawade, Pavan Chinchole

 

1Department of Pharmaceutical Quality Assurance Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, India, Email : zambare007@gmail.com

2Department of Pharmaceutical Quality Assurance Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, India, Email : shraddhashinde9625@gmail.com

3Department of Pharmaceutical Chemistry, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune 411018, India, Email: gawadevaibhav6060@gmail.com

4Department of Pharmaceutical Chemistry Dr. Rajendra Ghode College of Pharmacy, Amravati, Email :pavanchinchole@gmail.com

 

Corresponding Author: Dr. Zambare. Y.B., Assistant Professor, Pharmaceutical Quality Assurance, Dr. D.Y. Patil Institute of Pharmaceutical Sciences & Research. Email: zambare007@gmail.com Mob. 91 9766845044.

 

Citation: Yogesh Z, Shraddha S, Vaibhav G, Pavan C (2021) A Review On Clinical and Therapeutic Management of Gestational Diabetes Mellitus (GDM). J Pharm Exper Med, 2(2);1-6.

 

Copyright: © 2021, Dr. Zambare. Y.B. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.

 

ABSTRACT:

 

A high-performance thin-layer chromatographic method was developed and validated for estimation of AzilsartanKamedoxomil in pharmaceutical dosage form. The proposed method was applied successfully to the pharmaceutical analysis of the recently approved dosage form of AzilsartanKamedoxomil which is available in market as a brand name of Edarbi 40 tablets. The drugs were satisfactorily show peak with RF 0.58 for AzilsartanKamedoxomil. Method was validated according to the ICH guidelines. Accuracy and precision of the proposed method was evaluated by recovery studies (% recovery for Azilsartan Kamedoxomil was 99.49 %) and intra-day and inter-day precision studies. In stability testing, Azilsartan Kamedoxomil were found susceptible to acid hydrolysis and alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it can be used as a stability indicating method. The proposed validated stability indicating assay for the sensitive determination of the mentioned drugs is suitable for Quality control laboratories as a simple fast economic method. Degradation product of AzilsartanKamedoxomil in alkaline condition was carried out and its degradation product is successfully separated and isolated by HPTLC method. degradation product was identified by using MS-MS technique.

KEYWORDS:

AzilsartanKamedoxomil, HPTLC, Stability Indicating Assay, EDARBI 40 Tablets, Isolation of Degradation Product, MS-MS Identification.

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