Determination of the safe level of the new antidiabetic drug dapagliflozin in the air of the working area

2019 ◽  
Author(s):  
М.И. Голубева ◽  
◽  
И.А. Бобринева ◽  
М.В. Бидевкина ◽  
Э.А. Федорова ◽  
...  
Keyword(s):  
Antidiabetic Drug ◽  
Safe Level

scholarly journals DEVELOPMENT AND VALIDATION OF A TLC DENSITOMETRIC METHOD FOR DETERMINATION OF GLIMEPIRIDE IN TABLETS

2014 ◽  
Vol 16 (1) ◽  
pp. 11-15
Author(s):  
Yuni Retnaningtyas ◽  
Lestyo Wulandiri ◽  
Gabriella F Punu
Keyword(s):  
Pharmaceutical Analysis ◽  
Data Recovery ◽  
Antidiabetic Drug ◽  
Intermediate Precision ◽  
Quantification Limit ◽  
Accuracy And Precision ◽  
Quality Control Testing ◽  
The Mean ◽  
Development And Validation

A simple and valid TLC method has been developed for the determination of glimepiride in tablet formulation. After extraction of the analyte with a mixture of methanol and ammonia 0,2M (1:1, v/v), the extracts were spotted on precoated TLC silica gel F254 plates, which were developed with a mixture of toluene:methanol:ethyl acetate (75:20:5, v/v/v). Quantitative evaluation was performed by measuring the absorbance reflectance of the analyte spots at 238 nm. The method was validated for specificity, linearity, accuracy and precision. Good linearity was achieved in the concentration range 100–800 ng/spot. The RSD of repeatability and intermediate precision were found to be less than 2%, whereas the mean of the recovery data was 100-101%. The detection limit and quantification limit were 22 and 74 ng/spot, respectively. The method is specific, linear, precise, and accurate; it can be used for the routine quality control testing of marketed formulations.Keywords: glimepiride, TLC densitometric, validation of pharmaceutical methods, pharmaceutical analysis, antidiabetic drug Sebuah metode Kromatografi Lapis Tipis (KLT) yang sederhana dan valid telah dikembangkan untuk penentuan glimepiride dalam sediaan tablet. Setelah analit dalam sampel diekstraksi dengan campuran metanol dan amonia 0,2 M (1:1,v/v), ekstrak yang terlihat pada lempeng silika gel F254, yang dikembangkan dengan campuran toluen : metanol : etil asetat (75:20:5, v/v/v). Evaluasi kuantitatif dilakukan dengan mengukur reflektansi absorbansi noda analit pada panjang gelombang 238 nm.Metode ini divalidasi meliputi spesifisitas, linearitas, akurasi dan presisi.Linearitas yang baik dicapai pada rentang konsentrasi 100-800 ng / spot. RSD pengulangan dan presisi intermediate menunjukkan nilai kurang dari 2 %, sedangkan rata-rata data recovery adalah 100-101 % .Batas deteksi dan batas kuantifikasi adalah 22 dan 74 ng / noda.Metode ini spesifik, linear, tepat, dan akurat, bisa digunakan untuk pengujian kontrol kualitas rutin tablet glimepirid dipasarkan. Kata Kunci: glimepiride, TLC densitometric, validation of pharmaceutical methods, pharmaceutical analysis, antidiabetic drug

scholarly journals Development and Validation of New Analytical LC-MS/MS Method for the Estimation of Antidiabetic Drugs Ertugliflozin and Sitagliptin in Combined Pharmaceutical Dosage form

2021 ◽  
pp. 194-204
Author(s):  
Suleman S. Khoja ◽  
Laxman J. Patel
Keyword(s):  
Dosage Form ◽  
Antidiabetic Drug ◽  
Pharmaceutical Dosage Form ◽  
Column Temperature ◽  
Multiple Reactions ◽  
Highly Sensitive ◽  
Positive Mode ◽  
Development And Validation

Ertugliflozin and Sitagliptin is combination of Antidiabetic drug in tablet Steglujan 15 mg/100 mg film-coated tablets®, a member Antidiabetic drug, is a recent drug developed by Merck Sharp and Dohme Company for the treatment of Type 2 diabetes. Ertugliflozin and Sitagliptin can be used alone or in combination therapy. A highly sensitive, precise and accurate Liquid Chromatography with mass spectrometry (LC-MS/MS) method is developed and validated for the determination of Ertugliflozin and Sitagliptin in combined formulation. Chromatographic separation was carried out on Phenomenex Gemini, C18, (150 × 4.6 mm,5 μm) column. Isocratic method was based on 0.1% formic acid: acetonitrile (10:90, v/vas mobile phase, column temperature at 40°C and flow rate at 0.6 mL/minuteswere utilized. The mass spectrometer was operated under multiple reactions monitoring (MRM) mode using electrospray ionization by monitoring the transition pair (precursor to product ion) of m/z 437.10-328.95in the positive mode for Ertugliflozin and transition pair (precursor to product ion) of m/z 408.10-234.95 in the positive mode for Sitagliptin. The method was found linear in the concentration range of 15 to 450 ng/mL and 100–3000 ng/mL for Ertugliflozin and Sitagliptin respectively. The optimized method was validated according to the International Conference on Harmonization (ICH) and FDA guidelines. The developed method was found suitable for the quantitation of Ertugliflozin and Sitagliptin in Pharmaceutical dosage form.

scholarly journals Development and Validation of New RP-HPLC Method for the Estimation of Antidiabetic Drugs Metformin Hydrochloride and Gemigliptin in Combined Pharmaceutical Dosage Form

2021 ◽  
pp. 149-160
Author(s):  
Suleman S. Khoja ◽  
Laxman J. Patel
Keyword(s):  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Antidiabetic Drug ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Column Temperature ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Run Time

Metformin Hydrochloride and Gemigliptin is combination of Antidiabetic drug in tablet Zemimet SR ® Tablet (25/500 mg), a member Antidiabetic drug, is a recent drug developed by LG Life sciences for the treatment of Type 2 diabetes. A new sensitive and rapid HPLC method was developed for the determination of Metformin Hydrochloride and Gemigliptin in pharmaceutical dosage forms; it was validated according to International Conference on Harmonization and Food and Drug Administration guidelines. The analysis was performed on the HPLC system equipped with a using Gemni C18, (5 µm) (250 mm x 4.6 mm), with of Buffer (20mM Ammonium Acetate in water, pH 3.5) and Methanol: Acetonitrile 40:10 (%V/V) 60: 40 v/v with at a flow rate of 1.0 mL/min, column temperature 35°C, total run time was 10 min, injection volume 10 μl, and detection was performed at the wavelength (λ) of 265 nm. The calibration plot gave linear relationship over the concentration range of Metformin Hydrochloride 20, 40, 100, 200, 400 and 500 μg/ml, and Gemigliptin 1, 2, 5, 10, 20 and 25 μg/ml, respectively. The accuracy of the proposed method was determined by recovery studies and was found to be Metformin Hydrochloride 99.0 % to 101.0 % and Gemigliptin 98.0 % to 100.0 %.The Limit of Detection were 50.56 and 14.21 μg/ml for Metformin Hydrochloride and Gemigliptin, respectively and the Limit of Quantitation were 166.85 and 43.90 μg/ml for Metformin Hydrochloride and Gemigliptin, respectively% Relative Standard Deviation of the determination of precision was <2%. The results of robustness and solutions stability studies were within the acceptable limits as well the main features of the developed method are low run time and retention time of around 2.9 min for Metformin Hydrochloride (Met) and 7.4 min for Gemigliptin.

A Glassy Carbon Electrode for The Determination of Linagliptin Antidiabetic Drug in Pure, tablets and some biological fluids by Adsorptive Stripping Voltammetry

2020 ◽  
Vol 26 ◽  
Author(s):  
Ahmed A Gahlan ◽  
Ahmed M Haredy ◽  
Sayed M Derayea ◽  
Mahmoud A Omar ◽  
Gamal A Saleh
Keyword(s):  
Glassy Carbon Electrode ◽  
Glassy Carbon ◽  
Biological Fluids ◽  
Stripping Voltammetry ◽  
Carbon Electrode ◽  
Antidiabetic Drug ◽  
Quantitation Limit ◽  
Pharmaceutical Form ◽  
Voltammetric Technique

Aim: The present work provides a fast, simple, accurate, and inexpensive analytical method for the determination of Linagliptin (anti-diabetic drug). Methods: Using a square wave adsorptive anodic stripping voltammetric technique (SWAASV) and glassy carbon electrode (GCE) as a working electrode. The experimental and instrumental parameters were studied and discussed to ensure the validity of the method. Results: The method has a very good linearity (R2 = 0.9984), wide concentration range (0.189 - 2.268) µg mL -1 ), low detection limit 0.052 µg mL -1 and low quantitation limit 0.172 µg mL -1 . Conclusion: Linagliptin was determined successfully in pharmaceutical form, spiked urine and plasma with 99.67, 91.96, and 92.78 % recovery respectively by using the proposed method, and the results obtained were compared with other reported methods.

Determining Safe Levels of Mycotoxins

1984 ◽  
Vol 47 (7) ◽  
pp. 570-575 ◽  
Author(s):  
PAT B. HAMILTON
Keyword(s):  
Data Base ◽  
Field Data ◽  
Laboratory Data ◽  
Epidemiological Studies ◽  
Animal Experimentation ◽  
Laboratory Studies ◽  
Safe Level ◽  
Subjective Evaluations ◽  
Increasing Risk

The establishing of safe levels of mycotoxins to date has been a legal rather than scientific exercise. This has resulted in levels which have varied in response to economic and political pressures. The data base for rationally determining safe levels is very small. This has resulted in subjective evaluations of the worth of different studies in attempts to deduce safe levels from experiments designed to demonstrate effects, and in assumed safe levels which vary from field experiences. Using physiological parameters other than growth as criteria of safety, known deleterious interactions of mycotoxins with other factors, and statistical corrections for inadequate numbers of animals tested, permit better agreement between safe levels determined from laboratory data and from field data. However, the number of animals required makes impractical the laboratory determination of truly safe levels. Well-conceived and executed epidemiological studies coupled with laboratory studies designed to elaborate underlying principles appear to be the best approach to determining safe levels of mycotoxins. Until safe levels are based on sound animal experimentation, the prudent person would assume there is no truly safe level and that increasing levels of mycotoxins carry increasing risk.

Sign in / Sign up

Export Citation Format

Share Document