METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDY FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND INDAPAMIDE BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN PURE AND MARKETED FORMULATION.

Abstract

An approach of forced degradation study was successfully applied for the development of a stability-indicating assay method for simultaneous determination of telmisartan and indapamide in a formulation in the presence of its degradation products. The method showed adequate separation of Telmisartan and indapamide from their associated main impurities and degradation products. Separation was achieved on an Amazone C18, 5 microm, 150 x 4.6 mm the mobile phase (Buffer: acetonitrile: methanol) (45+25+30) KH2PO4 & Triethaylamine Ph 3.0 with ortho phosphoric acid buffer flow rate of 1 mL/min and UV detection at 285 nm. Comprehensive stress testing of telmisartan and indapamide Rt= 4.7 min, 10.7 min was according to the International Conference on Harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid hydrolysis, base hydrolysis, to apply stress conditions. There were no other coeluting, interfering peaks from excipients, impurities. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, and solution stability. The linearity of the proposed method was investigated in the range of 6-22.5 microg/mL (r2 = 0.999) for telmisartan and 11.2-42 microg/mL (r2 = 0.9997) for indapamide.

Authors and Affiliations

Patel Amit R* , Chandrul Kaushal Kishor

Keywords

Related Articles

Antimicrobial effect of Callus and Natural plant extracts of Premna serratifolia L

Premna serratifolia L. is an important medicinal shrub used in traditional system of medicines as cardio tonic, antibiotic, anti-coagulant, carminative, hepatoprotective, anti tumor etc. The present study aims in the eva...

Development and Validation of Derivative Spectrophotometric Method for Simultaneous Estimation of Domperidone and Rabeprazole Sodium in Bulk and Dosage Forms

The use of first order derivative spectroscophotometry allowed simultaneous determination of domperidone and rabeprazole sodium, in fixed dose combination products. The absorbance values at 253.2 nm and 266.4 nm of first...

Antifungal Activity of Embelia Ribes Plant Extracts

Aim of the present study was to investigate the antifungal activity of the Embelia ribes plant extracts using standard in vitro antifungal susceptibility test method like EUCAST (European Committee on Antimicrobial Susce...

DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR ESTIMATION OF MOZAVAPTAN IN HUMAN PLASMA USING LC-MS/MS

A simple, accurate liquid chromatography with tandem mass spectrometry (LC/MS-MS) method has been developed and validated in human plasma. The method employed liquid-liquid extraction. Samples containing Mozavaptan were...

METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDY FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND INDAPAMIDE BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN PURE AND MARKETED FORMULATION.

An approach of forced degradation study was successfully applied for the development of a stability-indicating assay method for simultaneous determination of telmisartan and indapamide in a formulation in the presence of...

Download PDF file
  • EP ID EP85667
  • DOI -
  • Views 181
  • Downloads 0

How To Cite

Patel Amit R*, Chandrul Kaushal Kishor (2011). METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDY FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND INDAPAMIDE BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN PURE AND MARKETED FORMULATION.. International Journal of Pharmaceutical and Biological Research, 2(1), 4-16. https://europub.co.uk/articles/-A-85667