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Quality by Design Based Approach for the Estimation of Telmisartan in Presence of Related Substances by RP-HPLC Method
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| Author:
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SACHIN GHOLVE, MOHAMMAD IMRAN ANEES, MARIA SAIFEE, JAIPRAKASH SANGSHETTI, OMPRAKASH BHUSNURE, ABUBAKAR SALAM BAWAZIR
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| Abstract:
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A rapid specific RP-HPLC method has been developed for the determination of telmisartan in presence of impurity in the pharmaceutical drug substances. The control of pharmaceutical impurities is currently a critical issue in the pharmaceutical industry. The International Council for Harmonization (ICH) has formulated a workable guideline regarding the control of impurities. The objective of the recent study was to develop and validate a HPLC method for the quantitative determination of process-related impurities of telmisartan in pharmaceutical drug substances. Telmisartan is an angiotensin II receptor antagonist used in the management of hypertension. Chromatographic identification of the impurities was carried out on Eclipse XDB Phenyl (250×4.6 mm) column is used for the development of the method. The mobile phase consists of buffer and acetonitrile. The flow rate of the mobile phase was 1.0 mL/min with gradient elution. The column temperature is 30°C ± 2°C and the detection wavelength is 296 nm. The injection volume is 10 µL. The method was validated for linearity in the range of 2-12 µg/ml concentration and the LOD &LOQ values obtained were 0.00005123 and 0.0001341 µg/ml respectively which specifies the method's sensitivity. The proposed method was successfully used to estimate the telmisartan in presence of related substances.
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| Keyword:
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Telmisartan, RP-HPLC, Impurities, linearity, validation, ICH Guidelines.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.04.673
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| Download:
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