UPLC Method for Estimation of Benazepril and Hydrochlorothiazide in Combined and Bulk Dosage Form, a Stability Indicator | Chapter 6 | Pharmaceutical Research: Recent Advances and Trends Vol. 5

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

QbD Approach to Stability Indicating HPLC Method for Estimation of Elbasvir and Grazoprevir by Green Assessment Method | Chapter 4 | Pharmaceutical Science: New Insights and Developments Vol. 2

Introduction: Green chemistry is widely used in worldwide manufacturing, government policy, educational practice, and technology development. The main purpose of the circular economy is to establish a balance between economic growth, resource sustainability, and environmental protection. The global need to adapt procedures to meet the objectives of green analytical chemistry (GAC) is a serious challenge for the pharmaceutical industry. High-performance liquid chromatography (HPLC), one of the techniques used most commonly at various stages in the pharmaceutical industry, generates a massive volume of organic hazardous waste.

Aim: To develop analytical quality by design-aided stability indicating green high-performance liquid chromatography (HPLC) method for estimation of Elbasvir and Grazoprevir in a dosage form.

Materials and Methods: The percentage of ethanol in the mobile phase, flow rate, and their overall impact on the responses, such as asymmetry, theoretical plates, and resolution, were the crucial chromatographic elements that were examined in order to optimise the procedure. The primary goal of green analytical chemistry (GAC) has been to provide environmentally safe analytical techniques. Consequently, the application of GAC principles in pharmacological analysis is essential. A rotatable central composite design was used, and the Zorbax C18 column (4.6 x 150 mm, 5 µm) with 0.1% Trifluoroacetic acid and ethanol (40:60 v/v) as components of a mobile phase flowing at a rate of 1.0 ml/minute was used to create the ideal conditions for chromatographic separation with a run time of 5 minutes. At 253 nm, photodiode array detection was performed.

Results: The retention times for EBS and GZP were 1.8 and 2.84 minutes, respectively. According to ICH recommendations, the proposed approach was validated, and stress tests demonstrated that Elbasvir and Grazoprevir are sensitive to acidic, basic, and oxidative stress conditions. An analytical eco-scale score evaluated the greenness profile, while a software-based evaluation.

Conclusion: The developed HPLC method is eco-friendly and shall be adopted in the routine quality control of Elbasvir and Grazoprevir in a tablet dosage form. The implementation of the green strategies in the pharma analysis will provide benefits for the analysts' healthier working environment, this technique will also help commercial and industrial lab research and testing departments adopt and evaluate the various combinations in bulk and dosage forms.

 

Author (s) Details

 

Charushila Bhangale
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Sachin Somwanshi
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Kiran Kotade
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Mayur Gaikar
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Please see the book here:-https://doi.org/10.9734/bpi/psnid/v2/4074