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Mohammad Nasir Uddin
Department of Chemistry, University of Chittagong
Computer Science & IT Medicine & Pharmacology

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Degradation Study of Ketorolactromethamine by a Validated UPLC Method Mohammad Nasir Uddin; Md. Al-Amin; Md. Nazmul Haque Mijan; Suman Das
Indonesian Journal of Pharmaceutical Science and Technology Vol 6, No 1 (2019)
Publisher : Indonesian Journal of Pharmaceutical Science and Technology

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (577.906 KB) | DOI: 10.24198/ijpst.v6i1.16508

Abstract

UPLC stability indicating method was developed for determining ketorolac tromethamine in its degradation study at different conditions. An isocratic mobile phase composition of 60:10:30 (v/v) containing CH3OH, CH3CN and 5mM NaH2PO4 and C18 column were used at a flow rate of 0.20 mL min-1. Satisfactory retention time was found 2.13±0.05 min at 320 nm when monitored by DAD detector. Forced degradation studies of ketorolac tromethamine was also performed at the following conditions: acid and basic hydrolysis, heat (50-70°C for 1 hr), photolytic (UV and sunlight for up to 3 hr), oxidation (3% hydrogen peroxide for 1 hr). Forced degradation study revealed that ketorolac degraded significantly under thermal conditions. In 1N acid and base hydrolysis, degradation was moderately significant and comparable. It was degraded marginally in 0.1N acid-base hydrolysis which was comparable to oxidative conditions. But in photolytic condition ketorolac shows insignificant degradation. Method was also applied to pharmaceutical formulation.Keywords: UPLC, Ketorolac tromethamine, pharmaceutical formulation, Forced degradation
Simultaneous Estimation of Ketorolactromethamine and Tiemonium methylsulphate in biofluids by a New Validated UPLC Method Mohammad Nasir Uddin; Monir Uddin; Md. Touhidul Kabir
Indonesian Journal of Pharmaceutical Science and Technology Vol 5, No 1 (2018)
Publisher : Indonesian Journal of Pharmaceutical Science and Technology

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (765.646 KB) | DOI: 10.24198/ijpst.v5i1.14381

Abstract

An UPLC method has been developed for the simultaneous determination of ketorolac Tromethamine and tiemonium methylsulphate in pharmaceutical and biosamples. Calibration curves were linear with correlation coefficient 0.9997 over a studied concentration range of (01-10μg m ) for both drugs. Method was found to be reproducible with relative standard deviation (RSD) for intra to be 0.32-0.99% for KTR and 0.40-1.01% for TMS and inter day precision to be 0.51-2.77% for KTR and 0.41-2.26% for TMS over the said concentration range. The mean recovery of the drug obtained from the intraday assay was 99.18-103.34% for KTR, 99.14-101.76% for TMS and inter-day assay at six different days was 99.39-102.04% for KTR and 98.08-103.78% for TMS. The LOD and LOQ were found to be 0.125 and 0.41μg mL-1, respectively for KTR  and 0.150 and 0.50 μg mL-1, respectively for TMS. Method was successfully validated as per ICH guidelines can be conveniently employed for routine quality control analysis of ketorolac tromithamine and tiemonium methylsulphate in pharmaceutical formulations and biological samples without any interference.
Co-Authors Md. Al-Amin Md. Nazmul Haque Mijan Md. Touhidul Kabir Monir Uddin Suman Das