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Journal of Liquid Chromatography & Related Technologies Volume 42, 2019 - Issue 15-16
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Original Articles

Application of chemometric approach for QbD-Enabled development and validation of an RP-HPLC method for estimation of methotrexate

Atul JainNational UGC Centre of Excellence in NanoBiomedical Applications, Panjab University, Chandigarh, India;
,
Sarwar BegUniversity Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, Panjab University, Chandigarh, India; ;Department of Pharmaceutics, School of Pharmaceutical Education & Research, Jamia Hamdard, New Delhi, India
,
Sumant SainiUniversity Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, Panjab University, Chandigarh, India;
,
Teenu SharmaUniversity Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, Panjab University, Chandigarh, India;
,
O. P. KatareUniversity Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, Panjab University, Chandigarh, India;
&
Bhupinder SinghNational UGC Centre of Excellence in NanoBiomedical Applications, Panjab University, Chandigarh, India; ;University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, Panjab University, Chandigarh, India; Correspondence[email protected] [email protected]
Pages 502-512 | Received 08 Mar 2019, Accepted 09 Mar 2019, Published online: 20 Jun 2019

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Lucas Chiarentin, Carla Gonçalves, Cátia Augusto, Margarida Miranda, Catarina Cardoso & Carla Vitorino. (2023) Drilling into “Quality by Design” Approach for Analytical Methods. Critical Reviews in Analytical Chemistry 0:0, pages 1-42.
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Aggarapu Susmitha, Galla Rajitha & Gireesh Kumar Eri. (2023) A comprehensive review on QbD driven analytical procedures developed for the analysis of various drugs. Journal of Liquid Chromatography & Related Technologies 46:1-5, pages 12-36.
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Ameeduzzafar, Ibrahim El-Bagory, Nabil K. Alruwaili, Syed Sarim Imam, Fadhel Ahmed Alomar, Mohammed H. Elkomy, Naveed Ahmad & Mohammed Elmowafy. (2020) Quality by design (QbD) based development and validation of bioanalytical RP-HPLC method for dapagliflozin: Forced degradation and preclinical pharmacokinetic study. Journal of Liquid Chromatography & Related Technologies 43:1-2, pages 53-65.
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Articles from other publishers (17)

Vaskuri G. S. Sainaga Jyothi, Harithasree Veerabomma, Chantibabu Katta & Jitender Madan. (2023) Computational quality-by-design strategy to validate high-performance liquid chromatography method for the estimation of meloxicam in bulk dosage forms and milk samples. Analytical Sciences.
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Shirleen Miriam Marques, Rupesh K. Shirodkar & Lalit Kumar. (2023) Analytical ‘Quality-by-Design’ paradigm in development of a RP-HPLC method for the estimation of cilnidipine in nanoformulations: Forced degradation studies and mathematical modelling of in-vitro release studies. Microchemical Journal 193, pages 109124.
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Saad Ali Alshehri, Shadma Wahab, Mohammad Khalid & Mohammad Ali Abdullah Almoyad. (2023) Optimization of chromatographic conditions via Box‒Behnken design in RP-HPLC-PDA method development for the estimation of folic acid and methotrexate in bulk and tablets. Heliyon 9:10, pages e20282.
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Datta Maroti Pawde, Syed Nazrin Ruhina Rahman, Srikanth Ponneganti, Abhinab Goswami, Roshan Murlidhar Borkar & Tamilvanan Shunmugaperumal. (2023) Analytical Quality-by-Design-Based Systematic Optimization of RP-HPLC Method Conditions to Analyze Simultaneously Chloroquine Phosphate and Flavopiridol in Stress-Induced Combined Drug Solution and Pharmaceutical Emulsions. Journal of Chromatographic Science 61:7, pages 665-677.
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Anjali Pant, Gajanand Sharma, Sumant Saini, Atul Jain, Ravi Pratap Barnwal, Gurpal Singh & Bhupinder Singh. (2023) Quality by design‐steered development and validation of analytical and bioanalytical methods for raloxifene: Application of Monte Carlo simulations and variance inflation factor. Biomedical Chromatography 37:8.
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Sivasanker Reddy Lingareddygari, Nageswara Rao RavikrindhiIshaq Mohammed BeludariDastagiri Reddy YennamMadana Gopal NookalaSurendra Kammari. (2023) Design of Experiment Approach for Method Development and Validation of Bilastine in Pure and Pharmaceutical Dosage form using RP-UFLC. Oriental Journal Of Chemistry 39:3, pages 736-745.
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Deepak Kumar, Amrendra Kumar, Vinay Kumar, Arjesh Raj, Raja Ram Mohan Rai, Vishal Baliyan & Nitish Kumar. (2023) A Comprehensive Review on Analytical Method Development using RP-HPLC and Recent Advances in Pharmaceutical Applications. Journal for Research in Applied Sciences and Biotechnology 2:2, pages 53-60.
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Vancha Harish, Waleed Hassan Almalki, Ahmed Alshehri, Abdulaziz Alzahrani, Madan Mohan Gupta, Sami I. Alzarea, Imran Kazmi, Monica Gulati, Devesh Tewari, Gaurav Gupta, Kamal Dua & Sachin Kumar Singh. (2023) Quality by Design (QbD) Based Method for Estimation of Xanthohumol in Bulk and Solid Lipid Nanoparticles and Validation. Molecules 28:2, pages 472.
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Rinki Verma & Manoj Kumar. (2022) Development and Optimization of Methotrexate Encapsulated Polymeric Nanocarrier by Ionic Gelation Method and its Evaluations. ChemistrySelect 7:48.
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Mousa Sha’at, Adrian Florin Spac, Iulian Stoleriu, Alexandra Bujor, Monica Stamate Cretan, Mihaela Hartan & Lacramioara Ochiuz. (2022) Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Metformin Hydrochloride in Tablet Dosage Forms by HPLC. Pharmaceutics 14:6, pages 1187.
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Syed Nazrin Ruhina Rahman, Oly Katari, Datta Maroti Pawde, Gopi Sumanth Bhaskar Boddeda, Abhinab Goswami, Srinivasa Rao Mutheneni & Tamilvanan Shunmugaperumal. (2021) Application of Design of Experiments® Approach-Driven Artificial Intelligence and Machine Learning for Systematic Optimization of Reverse Phase High Performance Liquid Chromatography Method to Analyze Simultaneously Two Drugs (Cyclosporin A and Etodolac) in Solution, Human Plasma, Nanocapsules, and Emulsions. AAPS PharmSciTech 22:4.
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Nabil K. Alruwaili. (2021) Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method. International Journal of Analytical Chemistry 2021, pages 1-12.
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Sarwar Beg, Ankit K Malik, Obaid Afzal, Abdulmalik Saleh Alfawaz Altamimi, Imran Kazmi, Fahad A Al-Abbasi, Waleed H Almalki, Md Abul Barkat, S M Kawish, Debi Prasad Pradhan & Mahfoozur Rahman. (2021) Systematic Development and Validation of a RP-HPLC Method for Estimation of Abiraterone Acetate and its Degradation Products. Journal of Chromatographic Science 59:1, pages 79-87.
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Sarwar Beg & Mahfoozur Rahman. 2021. Handbook of Analytical Quality by Design. Handbook of Analytical Quality by Design 87 97 .
Md Noushad Javed, Faheem Hyder Pottoo, Athar Shamim, Md Saquib Hasnain & Md Sabir Alam. 2021. Design of Experiments for Pharmaceutical Product Development. Design of Experiments for Pharmaceutical Product Development 151 169 .
Sumant Saini, Teenu Sharma, Asha Patel, Ranjot Kaur, S.K. Tripathi, O.P. Katare & Bhupinder Singh. (2020) QbD-steered development and validation of an RP-HPLC method for quantification of ferulic acid: Rational application of chemometric tools. Journal of Chromatography B 1155, pages 122300.
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Harpreet Singh, Atul Jain, Jasreen Kaur, Shailendra Kumar Arya & Madhu Khatri. (2019) Adsorptive removal of oil from water using SPIONs–chitosan nanocomposite: kinetics and process optimization. Applied Nanoscience 10:4, pages 1281-1295.
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