Online ISSN: 2515-8260

Keywords : validation


Quantitive Determination And Validation Of Cobafen (Lyophilizate 10mg For Preparation Of Solution For Injection)

Nilufar K. Abdullaeva; Raykhona A. Khusainova; Nilufar M. Rizaeva; Egor A. Pshenichnov

European Journal of Molecular & Clinical Medicine, 2020, Volume 7, Issue 3, Pages 3375-3390

Research objective: to conduct a quantitative determination of sodium diclofenac and vitamin B-12 in new lyophilic drug Cobafen using modern physicochemical methods of analysis.
Materials and methods. During the research we used the samples of commercially available substances of mecobalamin chloride produced by Apex Medichem Ltd. (India), D-mannitol manufactured by Shandong Tianli Pharm. Co. Ltd. (China) and polyvinyl pyrrolidone (PVP) produced by Merck (Germany), as well as chemical reagents by Sigma-Aldrich (USA) and Hi-Media (India). For spectrophotometry analysis we applied a UV-1800 double-beam spectrophotometer (Shimadzu, Japan) and Agilent 8453E single-beam spectrophotometer (Agilent Technologies, Germany). Besides, the study was carried out under conditions of reverse phase HPLC (Agilent 1280 gradient HPLC chromatograph (Agilent Technologies, USA) and LC-20 (Shimadzu, Japan)).
Results. Conducted 5 independent experiments for each formulation and each freezing mode showed that D-mannitol is the additive agent of choice. Besides, lyophilizates produced using D-mannitol corresponded to the indicated quality attribute. When analyzing mecobalamin by HPLC, it was established that the method of choice was PP with methanol: buffer solution (26.5:73.5), the optimal concentration in the analysis of mecobalamin is 2 mg / ml.
Conclusion. It was established that sharp freezing condition is the most preferred due to the saving in production cycle time. The proposed HPLC method for quantitative determination of the active substance in the drug, validated by all validation parameters, is included in the pharmacopoeial monographs of JURABEK LABORATORIES JV LLC

Method Development And Validation Of Cetirazine Hcl And Montelukast Sodium

Vancha Harish; Sanjeev Sahu

European Journal of Molecular & Clinical Medicine, 2020, Volume 7, Issue 7, Pages 5855-5874

The detection, quantification of pharmaceutical products is mainly done by a dominant technique known as HPLC. Chromatographic techniques is used to analyze the parameters and optimize the parameters which are used in the method development and its validation. The present work mainly focuses on the method development and its validation of the Montelukast sodium and Cetirizine hydrochloride. All the parameters optimized has given the précised values.

Development And Validation Of The Conductometric Titration Method Of Quantitative Determination Of Free Organic Acids In The Anise Fruits

Ulugbek A. Umarov; Olexander Yu. Maslov; Sergii V. Kolisnyk; Мuyassar Fathullaeva

European Journal of Molecular & Clinical Medicine, 2020, Volume 7, Issue 3, Pages 3874-3883

A conductometric titration method has been developed for determination of free organic acids in anise fruits. The direct acid base titration of free organic acids was carried as a titrant was used the standardized sodium hydroxide aqueous solution. The end-point of titration was fixed by a conductometric electrode. The calibration curve was found to be linear in the concentration range of 0.0112 - 0.0332 mg/cm3 (r2 = 0.9992). The percentage recovery was found to be in the range of 98.61 ‐ 101.25%. The intra-day and inter-day precision were 1.32% and 1.62%, respectively. The method was found to be accurate and precise, having relative standard deviation of less than 2%. The developed method was validated statistically by compliance with SPhU guidelines. The proposed method is simple, convenient, rapid and sufficiently precise and can be successfully applied for the quantitative determination of total free organic acids in anise fruits.

In Silico Investigation of Anticancer Potential of Polysubstituted Thiophenes Through Molecular Docking Tools

Nishu Singla

European Journal of Molecular & Clinical Medicine, 2020, Volume 7, Issue 7, Pages 4808-4830

Development of new drug candidates for the treatment of cancer is under keen investigation since last few decades. Overexpression of carbonic anhydrase enzyme leads to development of hypoxic cancer. Many drug candidates have been already reported against carbonic anhydrase, but they are associated with toxicity and drug resistance issues. Therefore, in order to develop new drug candidates as carbonic anhydrase inhibitors, we have designed a libarary of 96 compounds possessing two heterocyclic moieties (thiophene and triazole).The designed molecules were further subjected to molecular docking against carbonic anhydrase enzyme (PDB ID 1XPZ) using GOLD and MOE software. The Gold and MOE scores of all the compounds were calculated among which 6 best compounds were screened and their binding patterns with the receptor were observed. Further, ADME, drug likeliness and toxicity characteristics have been predicted by using Swiss ADME predictor and preAdme tool, Lazar and protox. All the parameters were in the specified limits and followed the Lipnski’s rule. However, compound 67 has showed best interactions when compared with internal ligand by forming hydrogen bond interactions with THR 200, HIS 94, THR 199 and metal interaction with Zn 262. Validation of docking procedure was done and RMSD value was found to be 1.76Å. Interactions of best 6 compounds were predicted on MOE software which showed similarity in the binding pattern as predicted by GOLD software