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Integrity organization

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Integrity organization 2023

Declaration of Management with Integrity of 2022

The Ultra Performance Liquid Chromatography (UPLC) was developed and validated for determination of Norfloxacin raw material. The chromatographic conditions using Acquity UPLC BEH C18 column, 2.1 × 100 mm, 1.7 μm, column maintained at 30 °C, using 0.1% trifluoroacetic acid solution and acetonitrile mixed by gradient system as a mobile phase, flow rate 0.4 mL/min, runtime 14 minutes per injection and PDA detector at 265 nm. The chromatographic system suitability meets the suitability requirements of the United States Pharmacopoeia 41th revision (USP41). The specificity and selectivity were proved by good separation of Norfloxacin from other related compounds including Norfloxacin related compound A, Norfloxacin related compound E, Norfloxacin related compound H, Norfloxacin related compound K and degradation products. The relationship between concentration and area under curve was linear over the range of 5 to 25 μg of Norfloxacin per mL with the correlation coefficient of 0.99998. The accuracy of the results assessed by percentage recoveries of three concentration levels i.e. 5, 15 and 25 μg/mL were 100.05, 100.83 and 101.12, respectively. The system precision, performed by 3 standard solutions gave % RSD of 0.10, 0.16 and 0.15. The intermediate precision was no statistical difference of the results when the analysts, instruments and days were changed. The variations of different batches of column, column temperature, injection volume, concentration of acid in mobile phase, and flow rate did not affect the chromatographic system suitability. Limit of detection and limit of quantitation were 0.06 and 0.18 μg/mL, respectively. The UPLC method for determination of Norfloxacin raw material is simple, specific, accurate, precise, and robust. It reduces working time and reagent expense. In addition, the advantage of using not extremely high column temperature is to prolong the column life time. Therefore, the proposed method is suitable for use as a standard method for the determination of Norfloxacin raw material. Key words: Norfloxacin, UPLC

According to The Narcotics Control Act of 2519 B.E., anybody who is detected morphine in urine at the 300 ng/ml cutoff threshold, they will be reported as the drugs user. However, opium, codeine, heroin, or morphine user can meet morphine in urine. However, 6MAM can use to identify using morphine and Codeine-morphine ratio above 1 use to identify using codeine. Thus, these sunstances can derive the sources of morphine. The aim of the present work was to derive the sources of morphine in body fluids and quantification of morphine correctly using on-line solid phase extraction-liquid chromatography-tandem mass spectrometry. morphine-d3 and 6MAM-d3 are used as internal standard. Extraction by online SPE. Separation was performed on an ion-exchange column and detected by tandem mass spectrometry with electron spray ionization, positive mode. The method was validated according to the FDA guidance. Limit of 6MAM detection is 1 ng /ml. The linear range of codeine and morphine were obtained from 100-2000 ng/mL. This developed method was successfully using for quantification of morphine in human urine and its source. Can apply the method for classification of drug user in routine job of department of medical science Keywords : Morphine, Codeine, Heroine, 6MAM, urine

Diclofenac Sodium tablet is a nonsteroidal anti-inflammatory drug (NSAID). It is used to treat mild to moderate pain, inflammatory of osteoarthritis, rheumatoid arthritis and acute gout attack. In the fiscal year 2019, Bureau of Drug and Narcotic collaborated with Food and Drug Administration Thailand randomly collected samples from manufacturers, importers and hospitals under Quality Assurance of Medicine program. A total of 23 samples with strength of 25 and 50 mg from one importer (1 registration number) and 8 local manufacturers (9 registration numbers) were evaluated according to the United States Pharmacopoeia (USP 41) for identification, assay, content of uniformity, dissolution and organic impurities. The analytical methods were verified prior to analysis. The survey showed that 21 samples (91 percentage) complied with the USP 41 specifications whereas only 2 samples failed in dissolution. These data will be published in the GREEN BOOK. Key words : Diclofenac Tablet, Diclofenac sodium, NSAID

Atorvastatin Calcium is an antilipidemic drug which is listed in Thai National List of Essential Medicines. In the fiscal year 2019, the Bureau of Drug and Narcotic performed the quality assurance of Atorvastatin Calcium Tablets in accordance with the United States Pharmacopeia (USP 41). The method was verified prior to sample testing. A total of 55 samples with strengths of 10, 20, 40 and 80 mg were collected from public hospitals and manufacturers which consisted of 1 registration number from 1 local manufacturer and 11 registration numbers from 2 overseas manufacturers. All samples presented satisfactory results which complied with pharmacopeial specifications by performing assay, uniformity of dosage unit, organic impuritiies and dissolution. The results indicated that Atorvastatin Calcium Tablets marketed in Thailand obtained satisfactory pharmaceutical characteristics. Keywords: atorvastatin calcium tablets, quality