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.
Journal Title: International Journal of Pharmaceutical and Biological Research - Year 2011, Vol 2, Issue 1
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
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