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Development and Validation of RP-HPLC Method for Determination of Hydrochlorothiazide, Amiloride Hydrochloride and Related Impurities in Bulk and Pharmaceutical Dosage Forms

Development and Validation of RP-HPLC Method for Determination of Hydrochlorothiazide, Amiloride... AbstractHydrochlorothiazide (HCZ) and Amiloride hydrochloride (AMH) are generally co-formulated in antihypertensive formulations. Different analytical methods have been developed for their simultaneous determination in their binary mixtures but none of them analyzed both drugs in the presence of related impurities of HCZ; Salamide (DSA) and Chlorothiazide (CTZ). Accordingly; a simple, sensitive and highly selective RP-HPLC method was developed for their simultaneous determination in pure form and pharmaceutical formulations. Chromatographic separation was carried out within 10 min using an ODS-C18 column (250×4.6 mm, 5 µm) using 0.05 MKH2PO4 : acetonitrile: triethylamine (90: 10: 0.3 by volume, pH 3.6) as mobile phase, flow rate 1.5 mL min−1 with UV detection at 260 nm.Calibration curves were builtin the range of 1-50, 1-20, 1-12 and 1-20 µg mL-1 for HCZ, AMH, DSA and CTZ, respectively. HCZ and AMH were successfully analyzed in their pure and pharmaceutical form. The results obtained were statistically compared to those obtained by the reported method with no significant difference, therefore the proposed method can be applied in routine quality control analysis of the drug products. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Development and Validation of RP-HPLC Method for Determination of Hydrochlorothiazide, Amiloride Hydrochloride and Related Impurities in Bulk and Pharmaceutical Dosage Forms

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Development and Validation of RP-HPLC Method for Determination of Hydrochlorothiazide, Amiloride Hydrochloride and Related Impurities in Bulk and Pharmaceutical Dosage Forms

Abstract

AbstractHydrochlorothiazide (HCZ) and Amiloride hydrochloride (AMH) are generally co-formulated in antihypertensive formulations. Different analytical methods have been developed for their simultaneous determination in their binary mixtures but none of them analyzed both drugs in the presence of related impurities of HCZ; Salamide (DSA) and Chlorothiazide (CTZ). Accordingly; a simple, sensitive and highly selective RP-HPLC method was developed for their simultaneous determination in pure form...
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Publisher
Taylor & Francis
Copyright
© 2015, Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2015.1026394
Publisher site
See Article on Publisher Site

Abstract

AbstractHydrochlorothiazide (HCZ) and Amiloride hydrochloride (AMH) are generally co-formulated in antihypertensive formulations. Different analytical methods have been developed for their simultaneous determination in their binary mixtures but none of them analyzed both drugs in the presence of related impurities of HCZ; Salamide (DSA) and Chlorothiazide (CTZ). Accordingly; a simple, sensitive and highly selective RP-HPLC method was developed for their simultaneous determination in pure form and pharmaceutical formulations. Chromatographic separation was carried out within 10 min using an ODS-C18 column (250×4.6 mm, 5 µm) using 0.05 MKH2PO4 : acetonitrile: triethylamine (90: 10: 0.3 by volume, pH 3.6) as mobile phase, flow rate 1.5 mL min−1 with UV detection at 260 nm.Calibration curves were builtin the range of 1-50, 1-20, 1-12 and 1-20 µg mL-1 for HCZ, AMH, DSA and CTZ, respectively. HCZ and AMH were successfully analyzed in their pure and pharmaceutical form. The results obtained were statistically compared to those obtained by the reported method with no significant difference, therefore the proposed method can be applied in routine quality control analysis of the drug products.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Mar 4, 2015

Keywords: Hydrochlorothiazide; Amiloride hydrochloride; Salamide; Chlorothiazide; RP-HPLC

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