ABSTRACT
Introduction@#It is important to standardize a tincture prepared from the herb and root of <i>Paeonia anomala<i> L, which is widely used as a sedative in traditional medicine, based on the results of the studies its chemical composition, biological and pharmacological activities. Moreover, there is a need to carry out a quantitative stability testing in order to establish the ability to maintain quality under certain storage condition, shelf-life and to develop suitable packaging information.@*Materials and methods@#Standardization parameters of prepared <i>Paeonia anomala</i> tincture have been evaluated according to WHO guidelines for the determination of crude drug material, plant preparations and finished products technical parameters, along with the Mongolian National Pharmacopoeian (MNP) and Russian XIV Pharmacopoeian methods for tincture. The color of a tincture, dry residue, special density, alcohol content, and microbiological content were determined according to the methods described in MNP. A qualitative analysis of biological active constituents has been evaluated by thin-layer chromatography, the total phenolic compounds were determined by the reaction with Folin Chicalteu reagent and total monoterpene glycosides by the reaction with hydroxylamine in alkaline solution and ferric (III) chloride following spectrophotometric examination, respectively.</br> The stability testing study was performed according to the “General requirements for the stability testing study of drug-active compounds” MNS-6439-2014 using the real-time methods for the standardization parameters of the tincture.@*Conclusions@#The standardized parameters of tincture prepared from the herb and root of <i>Paeonia anomala</i> L. were approved by the National Reference Laboratory for Food Safety analysis. Consequently, the Mongolian pharmacopoeian article on <i>Paeonia anomala</i> tincture was officially permitted under the number ҮФӨ-0327-2017.</br> The stability study of tincture was carried out according to the MNS-6439-2014 by real-time tests for 24 months which provided that the changes in tincture quality were within the permitted limits. Consequently, it can conclude that the storage condition and shelf-time of <i>Paeonia anomala</i> tincture are 2 years under not above 25°С.
ABSTRACT
Introduction@#Ciprofloxacin is a broad-spectrum antibiotic that acts against a number of bacterial infections. The study was carried out to examine the in vitro quality control tests for five leading brands of ciprofloxacin hydrochloride 500 mg tablet formulation, registered in Mongolia. The quality control parameters of five different brands of ciprofloxacin hydrochloride 500 mg tablets were determined weight variation, friability, hardness, and disintegration, dissolution and assay tests. In addition, 0 and first order kinetic models were applied for each sample.@*Method@#All the tablets were evaluated for conformity with British Pharmacopoeia (BP) and Mongolian Pharmacopoeia-National Formulary (MP-NF) standards.@*Results@#Among five brands of tablets Brand C had lower mean weight variation of 0.8% and Brand A had highest mean weight variation of 3.42%. For friability test Brand B had the lowest mean friability (0.57) and Brand A had highest mean friability (1.51). The percentages of the drug content of five brands of ciprofloxacin tablet were obtained in the following sequence: Brand E (98.4 %) < Brand C (100.3%) < Brand D (115.1%) < Brand A (138.5%) < Brand B (183.8%). E and C brands met the BP and MP-NF specifications for assay@*Conclusion@#The present study revealed that Brand A, B and D the leading brands of this tablet not met the quality control parameters as per pharmacopoeia specifications expect dissolution test for some brands (Brand A, Brand B).