Background The concomitant montelukast and bilastine are used as additive therapy for seasonal allergic rhinoconjuctivitis and mild to moderate asthma. According to the literature review, no UV-visible spectrophotometry method has been reported yet for simultaneous estimation of montelukast sodium and bilastine in their combined pharmaceutical dosage forms. Objectives Hence, five different multicomponent spectrophotometric methods were developed and validated for simultaneous estimation of montelukast sodium and bilastine using risk assessment-based enhanced analytical quality by design approach. Methods The method risk parameters identification and assessment were done by the RPN ranking and filtering method according to the ICH Q9 guideline. The wavelength for detections and solvents such as 0.1 N NaOH and 0.1 N HCl were found critical method parameters for the development of target methods. The developed methods were validated as per ICH Q2 (R1) guidelines. Results The developed and validated methods were applied for the assay of combined pharmaceutical dosage forms of montelukast sodium and bilastine and results were found in good agreement with their labelled claim. Conclusion The developed method did not include the usage of any organic solvent and a good alternative to the costly chromatography method. Hence, methods are eco-friendly and economical for the said estimation of bilastine and montelukast sodium. Highlights Development of five multicomponent spectrophotometric methods for simultaneous estimation of montelukast sodium and bilastine using risk-based AQbD approach. Assay of combined tablet dosage forms of montelukast sodium and bilastine using developed methods.
The fixed-dose combination (FDC) of montelukast sodium (MLS) and bilastine (BIL) is used for monotherapy in the patient with seasonal allergic rhinoconjuctivitis and asthma. According to the upcoming ICH (International Council for Harmonization) Q14 guideline, the development of the analytical method by the implementation of the Analytical Quality by Design (AQbD) approach based on principles of Quality Risk Management (QRM) and design of experiments (DoE) would be a regulatory requirement for the registration of new drug substance and product in ICH countries. Hence, a robust high-performance thin layer chromatography method has been developed, which was not previously reported for simultaneous estimation of MLS and BIL using risk and DoE-based enhanced AQbD approach. The analytical failure mode effect analysis (AFMEA) was started with the identification of potential analytical failure modes followed by their effect analysis by RPN ranking and filtering method. The DoE-based AFMEA was applied for optimization of high-risk analytical failure modes by central composite design using Design-Expert software. The method operable design ranges and control strategy was set for quality risk management throughout the lifecycle of the developed method. The developed method was validated as per ICH Q2 (R1) guideline. The method was applied for the assay of FDC, and results were found in compliance with the labeled claim.
Background Bosutinib is a small molecule BCR-ABL, and src tyrosine kinase inhibitor used for the treatment of chronic myelogenous leukaemia. According to published literature, no stability-indicating RP-HPLC method has been reported yet for estimation of bosutinib. Objective Hence, the stability-indicating RP-HPLC method has been developed for the stability study of bosutinib using risk and DoE-based enhanced analytical quality by design approach. Methods The risk-based analytical quality by design approach was applied by risk parameter identification and risk assessment by risk priority number (RPN) ranking and filtering method as per International Council for Harmonisation (ICH) Q9 guideline. The DoE-based AQbD approach was implemented by response surface analysis using a central composite design. The risk of critical method risk parameters was mitigated by navigation of design space and framing of control strategy. Results The chromatographic separation was performed using a C18 column and acetonitrile–1.0%, v/v triethylamine in water (pH 7.0 adjusted by ortho-phosphoric acid). The developed method was validated according to the ICH Q2 (R1) guideline.The developed and validated method was applied for the assay of bosutinib in pharmaceutical dosage forms. The developed method was extended for oxidative degradation kinetic study of bosutinib at different pH conditions. Conclusion The developed RP-HPLC method can be used as analytical tool for quality control and stability study of pharmaceutical dosage forms of bosutinib in pharmaceutical industry. Highlights Development and validation of Stability indicting RP-HPLC method for estimation of bosutinib by implementation of DoE and risk-based enhanced AQbD approach. Application of method for assay of pharmaceutical dosage forms and oxidative degradation kinetic study
Background In the recent scenario of green chemistry, the usage of organic solvent should be minimized in the development of the analytical method for the safety of the environment and analysts. Objective Hence, the RP-HPLC method has been developed as an economical and eco-friendly alternative to published RP-HPLC methods for the analysis of FDC of anti-hypertensive drugs to save time, resources, cost and organic solvent. Method The method has been developed by the implementation of an enhanced AQbD approach based on DoE-based AFMCEA. The AFMCEA was performed by identification of potential analytical failure modes followed by their risk assessment by RPN ranking and filtering method. The DoE-based AFMCEA was implemented for response surface analysis and mitigation of risk of high-risk analytical failure modes by BBD. The MODR and control strategy was set for lifecycle management of the developed method. Results The RP-HPLC method was developed using the Shimpack ODS C18 column and acetonitrile-water (pH 6.2) (42:58, %V/V). The method was found to be validated as per ICH Q2 (R1) guideline. The method was applied for the synchronous assay of fifteen FDC of antihypertensive drugs. Conclusion The developed method has fulfilled the requirements of numerous published RP-HPLC and HPTLC methods. Hence, this method is a multipurpose chromatography (M) method for synchronous estimation of FDC products of anti-hypertensive drugs. This method can be used as a multipurpose (M), economical (E), eco-friendly (E) and rapid (R), MEER-RP-HPLC for quality control of multiple FDC of anti-hypertensive drugs in the pharmaceutical industry. Highlights Development of MEER-RP-HPLC method for synchronous estimation of fifteen pharmaceutical dosage forms of anti-hypertensive drugs. Implementation of enhanced AQbD approach based on DoE-based AFMCEA in development of method and application of the method for assay of fifteen anti-hypertensive dosage forms.
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