This work aimed to create a speedy, precise, and selective HPTLC and RP-UHPLC method for analysing andrographolide in fi nished products and raw materials. Asian medicines are using Andrographis paniculata since long. It’s used to treat skin eruptions, boils, scabies, and chronic, unexplained fevers, all of which are caused by blood “abnormalities.” Liquid chromatographic methods were developed to separate andrographolide and its herbal dosage form. HPTLC chromatography employed a 10 by 10 cm aluminum plate coated with 0.2 mm of silica gel 60 F254 (E. Merck, Germany). Camag Linomat 5 applicator with 100 μL syringe was used to apply samples in 6 mm bands (Hamilton, Switzerland). 14 mm separated the two bands, and 150 nL sec-1 was applied. Mobile phase was dichloromethane, toluene, ethyl acetate, and formic acid (6:4:1:0.5). This chromatogram runs 80 mm. Camag TLC scanner measured density at 254 nm. Mean RF=0.69. The linear calibration curve covers 500–3000 ng/spot and has a 0.996 correlation coeffi cient. Limit of Detection: 31.5 ng; Limit of Quantitation: 95.48 ng. A validated RP-UHPLC method for quantifying andrographolide in extract and formulation has been established. UHPLC analysis was performed in isocratic mode, at room temperature, using acetonitrile: Water (0.2% acetic acid) (85:15, v/v) as mobile phase on a 250 mm 4.6 mm i.d., 5 μm Cosmosil C18 column. Detection was at 230 nm. Andrographolide has a 4.1 minute half-life. Between 10 and 60 g/mL, andrographolide was linear. The approach met or exceeded ICH’s linearity, precision, accuracy, and robustness
New medication combinations are introduced every day. As a result, various diseases and disorders are treated using a combination of several therapeutic medicines that each have a somewhat distinct mechanism of action. Therefore, it is crucial to develop methods of analyzing medicines employing a range of methods that may be utilized. A UV 730d (dad) absorbance detector, a 20 L injection loop, a sp 930d pump, a 4.6 by 100 mL C18 column (Agilent), and Chemstation software are all included in the setup: approximately 60 water and 40% methanol (pH 3.0 adjust with OPA). Maximum effi ciency was achieved when the system was operated at a wavelength of 233 nm. The procedure’s effi cacy was confi rmed by testing it against ICH guidelines. These techniques were found to be linear, precise, broad, and stable. The procedure was found to be easy, accurate, exact, aff ordable, and easy to use again and again. This means that olmesartan and hydrochlorothiazide, in both bulk form and fi nished products, can be tested for quality using the proposed methodologies.
Eff orts were attempted to create a bioequivalent Osmatic release tablet formulation of carbamazepine, with a drug release profi le comparable to that of the innovator product. Tablets were formulated using the wet granulation technique based on literature data and the innovative product’s characterization. It was discovered that the pioneer tablet had a fi lm coating. After reviewing the existing literature and patents, it was determined to use a non-infringing approach and create a fi lm-coated tablet with an equivalent bioavailability and dissolution profi le. Based of justifi cation, the optimized formulation has an F9 value of 90, which is excellent. The intention was to keep the same composition and only increase the size. Trial formulation 9’s formula and procedure fulfi lled the specifi ed physicochemical properties and dissolution profi le, which is equivalent to the reference product in various media, based on the results of several laboratory trials and evaluations. The extended-release was achieved by combining the rate-controlling polymer Natrosol 250L/Natrosol 250 H, a pH-dependent polymer, and Hypromellose. Compared to the innovator sample, the extended-release tablets were found to comply with the USP specifi cation. Stability tests on the optimised batch showed no major deviations, which is a positive result.
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