Stability indicating UPLC Method for the Estimation of Telmisartan Related Substances in Tablets Formulation
نویسنده
چکیده
A simple, precise, accurate stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the quantitative estimation of purity of Telmisartan drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its degradation products and impurities. The present method was developed using Waters Aquity BEH C18 (100 mm x 2.1 mm, 1.7 μ) column with mobile phase containing a gradient time programme of the solvents A and B. The wave length selected for monitoring eluted compounds were monitored at 290 nm, the run time was within 10 min, which Telmisartan and its seven impurities were well separated. Telmisartan was found to degrade significantly in acid stress condition when it was subjected for various stress conditions. The degradation products were well separated from main peak and its impurities, proving the stability-indication of the method. The present method was validated as per international conference on harmonization (ICH) guidelines with respect to precision, specificity, linearity, limit of detection, limit of quantification, accuracy, and robustness.
منابع مشابه
A stability-Indicating HPLC Method for Simultaneous Determination of Creatine Phosphate Sodium and its Related Substances in Pharmaceutical Formulation
The objective of the study was to develop a simple, specific and stability-indicating HPLC method for the simultaneous determination of creatine phosphate sodium (CPS) and its related substances in pharmaceutical formulation. Separation of creatine phosphate sodium from its major process impurities and degradation products was achieved on a Hypersil BDS C18 column (250 × 4.6 mm, 5 μm) with an a...
متن کاملA stability-Indicating HPLC Method for Simultaneous Determination of Creatine Phosphate Sodium and its Related Substances in Pharmaceutical Formulation
The objective of the study was to develop a simple, specific and stability-indicating HPLC method for the simultaneous determination of creatine phosphate sodium (CPS) and its related substances in pharmaceutical formulation. Separation of creatine phosphate sodium from its major process impurities and degradation products was achieved on a Hypersil BDS C18 column (250 × 4.6 mm, 5 μm) with an a...
متن کاملStability-indicating UFLC method for uncoupling and estimation of impurities in clopidogrel, aspirin and omeprazole in their tablet dosage form using PDA detection
In this paper a fast and novel stability-indicating ultra fast LC method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed. The separation of USP related substances of clopidogrel (A, B and C), aspirin (D), omeprazole (A, B and C) and few other unknown impurities was detected by using ultra fast liquid chroma...
متن کاملImpurity profiling and a stability-indicating UPLC method development and validation for the estimation of related impurities of halobetasol propionate in halobetasol propionate 0.05% (w/w) cream.
A simple, short and stability-indicating reverse phase-ultra-performance liquid chromatography method was developed and validated for the quantitative determination of related impurities of halobetasol propionate in halobetasol propionate 0.05% cream formulation. The proposed method was developed on an ACQUITY UPLC™ BEH Phenyl (2.1 × 100 mm, 1.7 µm) column at 40°C with a mobile phase containing...
متن کاملDevelopment and Validation of a Stability-Indicating RP-UPLC Method for Determination of Rosuvastatin and Related Substances in Pharmaceutical Dosage Form
A stability-indicating reversed phase ultra performance liquid chromatographic (RP-UPLC) method was developed for the determination of related substances in rosuvastatin calcium (ROSV) tablet dosage form. The chromatographic separation was achieved on an Acquity BEH C18 (100 mm × 2.1 mm, 1.7 μm) column with mobile phase containing a gradient mixture of solvent-A (0.1% trifluoroacetic acid) and ...
متن کامل