Development and comprehensive greenness assessment for MEKC and HPTLC methods for simultaneous estimation of sertaconazole with two co-formulated preservatives in pharmaceutical dosage forms

A simple and sensitive spectrophotometric method for the determination of ramipril and telmisartan in pharmaceutical dosage forms has been developed. The absorption maxima were found at 220nm for ramipril and 297nm for telmisartan using 0.1N NaOH as solvent. Beer’s law was obeyed for both the drugs in the concentration range of 2-10μg/ml with correlation coefficients 0.999 for both ramipril and telmisartan. The limits of detection for ramipril and telmisartan were found to be 0.142 and 0.405μg/mL respectively and the limits of quantitation were 0.43 and 1.22μg/mL. Accuracy of the method was verified by performing recovery studies using simultaneous equation method and found to be 98.33 to 99.54%w/w for ramipril and 99.36 to 99.82 %w/w for telmisartan. %RSD of repeatability and intermediate precision studies were found to be <2 for both the drugs. Ruggedness of the method was checked by changing analyst worked and instrument used. In both the cases, the %RSD was found to be less than 2.

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Quality Risk Management-Based AQbD Approach to Development of VEER Chromatography Method for the Estimation of Multiple Combined Formulations of Anti-Hypertensive Drugs

Journal of AOAC International ◽

10.1093/jaoacint/qsaa140 ◽

2020 ◽

Author(s):

Pintu B Prajapati ◽

Mukti A Thakor ◽

Kunjan B Bodiwala ◽

Shailesh A Shah

Keyword(s):

Risk Management ◽

Dosage Forms ◽

Simultaneous Estimation ◽

Chromatography Method ◽

Pharmaceutical Dosage Forms ◽

Quality Risk Management ◽

Screening Design ◽

Quality Risk ◽

Quality By Design Approach ◽

Risk Parameters

Abstract Background A number of chromatography methods for estimating combined dosage forms of telmisartan have been published in the literature, but each combined dosage form needs separate chromatography conditions for analysis. Objective The versatile, economical, eco-friendly, and robust chromatographic method has been developed for simultaneous estimation of multiple combined pharmaceutical dosage forms of anti-hypertensive drugs using the analytical quality by design approach based on principles of quality risk management (QRM) and design of experiment (DoE). Method Analytical QRM was performed by identifying probable method risk parameters and risk assessment for the development of the method. DoE was performed by Taguchi Orthogonal Array (OA) screening design and Box-Behnken response surface design using Design-Expert software (trial version). Chromatographic separation was performed using silica gel 60 GF254 as stationary phase and toluene:ethyl acetate:methanol:glacial acetic acid (5.5 + 2 + 1 + 0.2, v/v/v/v) as a mobile phase keeping saturation time of 15 min. The developed method was applied for the assay of six combined pharmaceutical dosage forms of anti-hypertensive drugs. Results The developed method was found to be validated for accuracy, precision, specificity, linearity, LOD, LOQ, and robustness as per ICH guideline. The results of the assay were found in good agreement with the labelled claim. Conclusions The developed method can be applied for analysis and quality control of multiple combined dosage forms of telmisartan. Highlights A QRM and DoE-based AQbD approach was applied for development of chromatography method for simultaneous estimation of multiple combined dosage forms of telmisartan. The developed method was successfully applied for simultaneous estimation of six different multiple combined dosage forms of temisrtan.

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