Objective: The present study aimed to develop stability indicating the UPLC technique for simultaneous estimation of Benazepril and Hydrochlorothiazide in bulk and formulation.
Background: Benazepril and benazeprilat inhibit the
angiotensin-converting enzyme (ACE) in both humans and animals. There are
several possible combinations of angiotensin-converting enzyme inhibitors or
angiotensin II receptor blockers with hydrochlorothiazide.
Methods: The mobile phase consisted of 0.1% Triethylamine
phosphate: Methanol (25:75v/v) was used. Benazepril linearity was found to be
4-20 µg/ml and Hydrochlorothiazide linearity was found to be 5-25 µg/ml.
Quantification was performed using ultraviolet detection at 236 nm based on the
overlay UV spectrum and the retention period of Benazepril was 3.4 min and
Hydrochlorothiazide was 5.4 min with a flow rate of 1.0 ml/min. According to
the ICH guidelines, the proposed method was validated and stress studies
revealed that the drugs are prone to alkali and peroxide stress conditions.
Results: The calibration curve was plotted, and the regression
equation for Benazepril was y = 2,01,491.67x + 60,532.30 with a correlation
coefficient (r2) of 0.9997
and Hydrochlorothiazide was y = 64,635.86x - 74,607.10 with a correlation
coefficient (r2) of 0.9994. According to the accuracy research, the
percent recovery of Benazepril is 99.09-100.69% and that of Hydrochlorothiazide
is 98.27-101.88%, both of which are within the ICH recommendations. Benazepril
has a limit of detection of 0.08 g/ml-0.24 g/ml and Hydrochlorothiazide has a
limit of quantitation of 0.03 g/ml - 0.10 g/ml. The procedure was found to be
straightforward, linear, rapid, exact, repeatable, and robust. It was
determined that the % RSD was within ICH norms. The drug's susceptibility to
oxidative, thermal, photolytic, acidic, basic, and neutral hydrolysis stress
conditions was demonstrated by stress degradation testing. The medication was
shown to break down most quickly in alkali and peroxide-stressed conditions.
Conclusion: The degradation products generated during the
stability investigation were well isolated from the pure drugs, revealing the
uniqueness of the developed technique. The developed chromatographic technique
under consideration was suitable for the accurate, precise, and quick
simultaneous measurement of hydrochlorothiazide and benazepril in both their
bulk and medicinal dose forms.
Author(s) Details
Shraddha
S. Bodke
Department of Pharmaceutical Quality Assurance, PRES’s College of
Pharmacy (For Women), Chincholi,
Nashik, India.
Charushila
J. Bhangal
Department of Pharmaceutical Quality Assurance, PRES’s College of
Pharmacy (For Women), Chincholi, Nashik, India.
Sangita
N. Bhandare
Department of Pharmaceutical Chemistry, PRES’s College of Pharmacy
(For Women), Chincholi, Nashik, India.
Please
see the book here:- https://doi.org/10.9734/bpi/prrat/v5/1734
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