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The Thai Journal of Pharmaceutical Sciences

Validation

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Full-Text Articles in Life Sciences

Application Of Fluorotag In Quantification Of Metformin In Tablet Dosage Form And Biological Samples, Panikumar Durga Anumolu, Sunitha Gurrala, Sahitya Menkana, Ceema Mathew, Lavanya Srimantula Jan 2022

Application Of Fluorotag In Quantification Of Metformin In Tablet Dosage Form And Biological Samples, Panikumar Durga Anumolu, Sunitha Gurrala, Sahitya Menkana, Ceema Mathew, Lavanya Srimantula

The Thai Journal of Pharmaceutical Sciences

Background: New specific and sensitive spectrofluorimetric fluorotag method has been developed and validated for the quantification of metformin hydrochloride. Materials and Methods: The derivatization reaction was carried out using 1,2-naphthoquinone-4-sulfonic sulfonate as (NQS) fluorotag in the presence of strong alkaline medium (potassium hydroxide) to form the highly fluorescent product. The fluorescence was observed at emission wavelength 453 nm after excitation at 359 nm. The different experimental conditions affecting the reaction product formation and stability were carefully studied and optimized as 2% w/v of potassium hydroxide solution, 0.5% w/v NQS reagent. Results: At optimum reaction conditions, good linear relationship was found …


Analytical Method For Simultaneous Estimation Of Ranolazine And Metformin Hydrochloride By Validated Rp-Hplc-Dad Method, Ashok B. Patel, Dhruvanshi A. Gol, Rahul L. Makwana, Amitkumar J. Vyas, Ajay I. Patel, Nilesh K. Patel, Shital D. Faldu, Arvind N. Lumbhani Jan 2022

Analytical Method For Simultaneous Estimation Of Ranolazine And Metformin Hydrochloride By Validated Rp-Hplc-Dad Method, Ashok B. Patel, Dhruvanshi A. Gol, Rahul L. Makwana, Amitkumar J. Vyas, Ajay I. Patel, Nilesh K. Patel, Shital D. Faldu, Arvind N. Lumbhani

The Thai Journal of Pharmaceutical Sciences

Background: In the present study, a simple, sensitive, rapid, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method with diode array detection was developed and validated for simultaneous estimation of Metformin hydrochloride (MET) and Ranolazine (RANO) in a synthetic mixture. Material and Method: The method was developed using isocratic elution mode on a reversed-phase. Chromatographic separation was performed on ACE CN C18 (250 mm, 4.5 mm, 5 μm) column and a mobile phase consisting of methanol: acetonitrile:ammonium formate (45:45:10% v/v/v) with 10% formic acid to adjust the pH to 6.0, at a flow rate of 1.0 ml/min. Detection and quantification …


Prospective Process Validation For The Manufacture Of Ketoprofen Fast Dissolving Tablets, Mariam Omari, P. Rashmi, G.S. Shantha Kumar, Pratiksha Patil, Arijit Das Jan 2021

Prospective Process Validation For The Manufacture Of Ketoprofen Fast Dissolving Tablets, Mariam Omari, P. Rashmi, G.S. Shantha Kumar, Pratiksha Patil, Arijit Das

The Thai Journal of Pharmaceutical Sciences

As validation is an integral part of current good manufacturing practice, nowadays, it is practiced in all pharmaceutical industries to assure that the manufacturing process is in control and products of high quality are obtained. Building of quality needs attention in the manufacturing process, from the raw materials to finalized product. The current research work is to perform prospective process validation for the manufacture of ketoprofen fast dissolving tablets (FDT) of 50 mg dose. Various trials and challenge studies were done to finalize critical process parameters. Three consecutive batches of ketoprofen FDT with the same batch size, procedure, equipment, and …


Hptlc Method For Simultaneous Estimation Of Ramipril And Losartan Potassium In Pharmaceutical Dosage Form: Development And Validation Consideration, Darshana A. Parmar, Dinesh V. Thakkar, Rashmin B. Patel, Mrunali R. Patel Jan 2015

Hptlc Method For Simultaneous Estimation Of Ramipril And Losartan Potassium In Pharmaceutical Dosage Form: Development And Validation Consideration, Darshana A. Parmar, Dinesh V. Thakkar, Rashmin B. Patel, Mrunali R. Patel

The Thai Journal of Pharmaceutical Sciences

This paper describes validated high-performance thin-layer chromatography (HPTLC) methods for simultaneous estimation of ramipril (RAM) and losartan potassium (LOS) in pure powder and formulation. The HPTLC separation was achieved on an aluminum-backed l...


Stability Indicating Rp-Hplc Method For Estimation Of Bamifylline Hydrochloride In Tablet Formulation: Development And Validation Consideration, Rashmin. B. Patel, Mrunali. R. Patel, Tapan S. Goswami Jan 2014

Stability Indicating Rp-Hplc Method For Estimation Of Bamifylline Hydrochloride In Tablet Formulation: Development And Validation Consideration, Rashmin. B. Patel, Mrunali. R. Patel, Tapan S. Goswami

The Thai Journal of Pharmaceutical Sciences

A simple, specific and robust stability indicating high performance liquid chromatographic (HPLC) method for estimation of bamifylline hydrochloride was developed and validated. Bamifylline hydrochloride was separated and quantitated on Inertsil ODS-3V c...


Development And Validation Of Rp-Hplc Method For Quantitative Analysis Of Individual Y-Oryzanol In Cold Pressed Rice Bran Oil, Apirak Sakunpak, Jirapornchai Suksaeree, Laksana Charoenchai, Chaowalit Monton, Pathamapom Pathompak, Tossaton Charoonratana, Krisana Kraisintu Jan 2013

Development And Validation Of Rp-Hplc Method For Quantitative Analysis Of Individual Y-Oryzanol In Cold Pressed Rice Bran Oil, Apirak Sakunpak, Jirapornchai Suksaeree, Laksana Charoenchai, Chaowalit Monton, Pathamapom Pathompak, Tossaton Charoonratana, Krisana Kraisintu

The Thai Journal of Pharmaceutical Sciences

No abstract provided.


Development And Validation Of An Instrument To Assess The Attitudes Of Patients With Diabetes(การสร้างและทดสอบความตรงของเครื่องมือเพื่อใช้วัดทัศนคต..., Supakit Wongwiwatthananukit, Sarinee Krittiyanunt, Aunchalee Wannapinyo Jan 2004

Development And Validation Of An Instrument To Assess The Attitudes Of Patients With Diabetes(การสร้างและทดสอบความตรงของเครื่องมือเพื่อใช้วัดทัศนคต..., Supakit Wongwiwatthananukit, Sarinee Krittiyanunt, Aunchalee Wannapinyo

The Thai Journal of Pharmaceutical Sciences

The purpose of this methodological study was to develop a reliable and valid instrument to assess attitudes of patients with diabetes. This study was implemented through three major steps: (1) instrument development, (2) expert review of the instrument, ...


Development And Validation Of An Instrument To Assess The General Knowledge Of Patients With Diabetes(การสร้างและทดสอบความตรงของเครื่องมือเพื่อใช้วัดควา..., Supakit Wongwiwatthananukit, Sarinee Krittiyanunt, Aunchalee Wannapinyo Jan 2004

Development And Validation Of An Instrument To Assess The General Knowledge Of Patients With Diabetes(การสร้างและทดสอบความตรงของเครื่องมือเพื่อใช้วัดควา..., Supakit Wongwiwatthananukit, Sarinee Krittiyanunt, Aunchalee Wannapinyo

The Thai Journal of Pharmaceutical Sciences

The purpose of this methodological study was to develop a reliable and valid instrument to assess the general knowledge of diabetic patients. The study was implemented through three major steps: (1) instrument development, (2) expert review of the instru...