Method development and validation of telmisartan in bulk and pharmaceutical dosage forms by UV spectrophotometric method

Kishanta Kumar Pradhan; Uma Shankar Mishra; Aurobindo Sahoo; Kanhu Charana Sahu; Debananda Mishra; Ranjit Dash

Kishanta Kumar Pradhan ⁽¹⁾ , Uma Shankar Mishra ⁽²⁾ , Aurobindo Sahoo ⁽³⁾ , Kanhu Charana Sahu ⁽⁴⁾ , Debananda Mishra ⁽⁵⁾ , Ranjit Dash ⁽⁶⁾

(1) Department of Pharmaceutical Analysis & Quality Assurance, Royal College of Pharmacy and Health Sciences, Andhapasara Road, Berhampur, Odisha, India, India ,

(2) Department of Pharmaceutical Analysis & Quality Assurance, Royal College of Pharmacy and Health Sciences, Andhapasara Road, Berhampur, Odisha, India, India ,

(3) Department of Pharmaceutical Analysis & Quality Assurance, Royal College of Pharmacy and Health Sciences, Andhapasara Road, Berhampur, Odisha, India, India ,

(4) Department of Pharmaceutical Analysis & Quality Assurance, Royal College of Pharmacy and Health Sciences, Andhapasara Road, Berhampur, Odisha, India, India ,

(5) Department of Pharmaceutical Analysis & Quality Assurance, Royal College of Pharmacy and Health Sciences, Andhapasara Road, Berhampur, Odisha, India, India ,

(6) Department of Pharmaceutical Analysis & Quality Assurance, Royal College of Pharmacy and Health Sciences, Andhapasara Road, Berhampur, Odisha, India, India

Issue
Vol. 2 No. 4 (2011): Volume 2 Issue 4

Keywords:

Analytical Method, Telmisartan, UV Spectroscopy, Validation

PDF

Abstract

This paper describes the analytical method suitable for validation of Telmisartan by UV Spectrophotometric method. The method utilized UV spectroscopy (Shimadzu, model 1700).The solvent system was consists of Methanol: water in the ratio of 90:10 at wave length (λ_max) 298 nm. Validation experiments were performed to demonstrate System suitability, Specificity, Precision, Linearity, Accuracy Interday assay, intraday assay, robustness, ruggedness, LOD, &LOQ. The method was linear over the concentration range of 5-45 mg/ml. The method was showed good recoveries (98.04- 101.04%) and the recovery studies were carried out by adding different amounts (80%, 100% & 120%) of bulk samples of Telmisartan. The Proposed method was simple, sensitive &reliable with good Precise, Accurate, and Reproducible and rapid for the determination of Telmisartan. While estimating the commercial formulation without interference of excipients & other additives hence this method can be used for routine determination of Telmisartan in bulk and their pharmaceutical dosage forms.