ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE AND TELMISARTAN HYDROCHLORIDE IN MULTICOMPONENT TABLET DOSAGE FORM AND IN BIORELEVANT MEDIA (FASSIF) BY RP-HPLC TECHNIQUES
Keywords:
Hydrochlorothiazide (HTZ), Amlodipine besylate (AML) and Telmisartan hydrochloride (TLM), RP-HPLC, Validation, FaSSIFAbstract
Objective: A simple, rapid, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous analysis of Hydrochlorothiazide (HTZ), Amlodipine besylate (AML) and Telmisartan hydrochloride (TLM) in a tablet dosage form and in Biorelevant media has been developed and validated.
Methods: This method was performed with a thermosil C18 (4.6 × 100 mm i. d., 3.7 μm particle column with 40:60 (v/v) 20 mM potassium dihydrogen orthophosphate buffer: methanol as mobile phase at a flow rate of 1.0 ml/min. UV detection at 248 nm.
Results: By the method HTZ, AML and TLM were eluted with retention times of 1.823, 2.639, and 4.198 min, respectively. The method was continued and validated accordance with ICH guidelines. Validation revealed the method is rapid, specific, accurate, precise, reliable, and reproducible. Calibration curve plots were linear over the concentration ranges 6.25-100μg/mL for HTZ, 2.5-40μg/mL for AML, and 20-320μg/mL for TLM. Limits of detection (LOD) were 0.004, 0.0016, and 0.0128μg/ml and limits of quantification (LOQ) were 0.013, 0.0052, and 0.0416μg/mL for HTZ, AML and TLM respectively.
Conclusion: The statistical analysis was proves the method is suitable for the analysis of HTZ, AML and TLM as a bulk, in tablet dosage form and in biorelevant media without any interference from the excipients. It was also proved study for degradation kinetics of three drugs. It may be extended for its estimation in plasma and other biological fluids.
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