Spectrophotometric and Chemometric Methods for Simultaneous Determination of Two Anti-Hypertensive Drugs in their Combined Dosage Form

Background According to the green chemistry approach, during method development, the usage of toxic and carcinogenic organic solvents should be avoided or minimized for the safety of the environment and analysts. The chromatographic methods such as RP-HPLC and HPTLC include the usage of class 2 organic solvents as per ICH Q3C (R6) guideline. The chromatographic analysis by HPTLC requires less organic solvent as compared to the RP-HPLC method. Objective Hence, HPTLC-based chromatographic analysis of vildagliptin (VIL) and remogliflozin Etabonate (RMG) has been carried out using green chemistry and AQbD approaches. Method The PCA-based chemometric analysis was applied for the identification of critical method variables for the development of the method. The DoE-based Box-Behnken design was applied for response surface modelling and optimisation of critical method variables. The analytical design space and analytical control point were navigated for the development of the HPTLC method as per QTAP. Results The chromatographic analysis of VEL and RMG was carried out using silica gel G60 F254 as stationary phase and acetone - ethyl acetate -water-TEA (7.0 + 2.5 + 0.3 + 0.2, v/v) as mobile phase. The HPTLC method was validated as per ICH Q2 (R1) guideline. The HPTLC method was applied for the assay of FDCs of VIL and RMG and the results were found to comply with their labelled claim. Conclusion The developed method included the usage of organic solvents which are belonging to the class-3 category as per the ICH Q3C (R6) guideline. Hence, the developed method can be used as an eco-friendly alternative to published chromatographic methods for quality control and routine analysis of FDCs of VIL and RMG in the pharmaceutical industry. Highlights Chromatographic analysis of vildagliptin and remogliflozin etabonate using green chemistry and AQbD approaches. Application of the method for assay of drugs in their combined pharmaceutical dosage forms.

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Green Easily Implemented Spectrophotometric Methods for Concurrent Determination of Ephedrine Hydrochloride and Naphazoline Nitrate in Nasal Preparations Containing Methylparaben

Abdelfatah

Magdy

2023

Journal of AOAC International

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Background Spectrophotometric resolution of a mixture of several drugs is considered a cheaper, simpler and more versatile alternate compared to the costly chromatographic instruments. Objective The work aims to resolve the interfering spectra of ephedrine hydrochloride, naphazoline nitrate and methylparaben in nasal preparations using smart spectrophotometric methods. Methods In our work, derivative and dual wavelength methods were combined to eliminate this interference, under the name of derivative dual wavelength method. Other methods, namely successive derivative subtraction and chemometric analysis were also able to eliminate this interference. The methods have proven their applicability as they follow the ICH requirements regarding repeatability, precision, accuracy, selectivity, and linearity. Eco- scale, GAPI and AGREE tools were used to estimate the possible environmental effects of the methods. Results Acceptable results of repeatability, precision, accuracy, selectivity, and linearity were obtained. LOD values were 2.2 for ephedrine and 0.3 for naphazoline. The correlation coefficients were above 0.999. The methods were proven to be safe for application. Conclusion The introduced methods are cheap and easily implemented compared to chromatographic techniques. They can be used in purity checking of raw material and estimation of concentrations in market formulations. The replacement of the published chromatographic techniques with our developed methods is usefulwhen saving money, effort and time is needed. Highlights The three components of a decongestant nasal preparation were determined using cheap green versatile spectrophotometric methods that keep the advantages of chromatographic techniques including accuracy, reproducibility and selectivity.

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Spectrophotometric and Chemometric Methods for Simultaneous Determination of Two Anti-Hypertensive Drugs in their Combined Dosage Form

Cited by 5 publications

References 45 publications

Sustainable quantification of glycopyrronium, indacaterol, and mometasone along with two genotoxic impurities in a recently approved fixed-dose breezhaler formulations and biological fluids: A machine learning-augmented UV-spectroscopic approach

Sustainable quantification of glycopyrronium, indacaterol, and mometasone along with two genotoxic impurities in a recently approved fixed-dose breezhaler formulations and biological fluids: A machine learning-augmented UV-spectroscopic approach

Chemometric-Based AQbD and Green Chemistry Approaches to Chromatographic Analysis of Remogliflozin Etabonate and Vildagliptin

Green Easily Implemented Spectrophotometric Methods for Concurrent Determination of Ephedrine Hydrochloride and Naphazoline Nitrate in Nasal Preparations Containing Methylparaben

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