degradation

Teneligliptin hydrobromide hydrate is a new FDA approved drug for treatment of Diabetes Mellitus. Very few methods have been reported for its identified degradation products and their effects on human. A simple, rapid, precise and accurate stability indicating RP-HPLC method was developed and validated for identification of Teneligliptin hydrobromide hydrate and its degradants on Kromacil C18 column using pH 5.5 phosphate buffer and methanol (75:25v/v) as a mobile phase in isocratic mode of elution at a flow rate 1.2 ml/min. The column effluents were monitored by a variable wavelength UV detector at 270 nm. The method was validated as per ICH guidelines. Forced degradation studies of Teneligliptin hydrobromide hydrate were carried out under acidic, basic, neutral, peroxide, photo and thermal conditions. Degradation was observed in basic and neutral stress samples, but not in acid, peroxide, photo and thermal stress samples.

This study examines the stability of paracetamol pediatric oral suspension (120mg/5ml) in simulated in-home storage conditions, temperature ranging from (300±5C/65±5RH) representing room condition. Samples from suspension were assayed for active pharmaceutical ingredient and tested for related substance (degradants) using B.P 2012 pharmacopeia HPLC method. The study was carried out in day zero, seven, fourteen, thirty and forty five.  The instrument utilize column ® C8, 100 x 4.6 mm, 3.5 μm particle size. The flow rate was 1.5 ml/minute. The mobile phase consisted of methanol, tetrabutylammonium hydroxide and sodium orthophosphate buffer. The results obtained showed that the drug assay content was out of the limits from day zero Furthermore, the half live was found to be 35.06 days

Co-amoxiclav for pediatric use comes as oral powder, which has to be reconstituted before administration. Concerns have been raised regarding the appropriateness of environmental conditions. A stability study was carried out on the original brand (Augmentin) suspension which were reconstituted and kept under the standard storage conditions of 2-8ºC and at home conditions (25ºC). Both compounds (amoxicillin and clavulanic acid) were considered stable if they retained 90% of their initial concentrations. From the study, it was found that the home conditions had no significant detrimental effect on the stability of amoxicillin but had a significant on stability of clavulanic acid, throughout the duration of therapy (10 days). However. The standard storage temperature should be adhered to stringently to guarantee maximum therapeutic benefit. This revealed that amoxicillin remained stable throughout the duration of therapy but clavulanic acid did not. Physical compatibility was assessed by visual observation for discoloration and precipitation throughout the duration of therapy. The chemical stability of the drug was analyzed by HPLC instrumental method. The various parameters analyzed include description, odor, color, taste, assay, water content, specific gravity, and pH. These parameters were evaluated at zero day, 3rd day, 7th day, 10th day intervals. The results of assay indicate that the samples are within the allow able limits (90-120%) for amoxicillin at recommended conditions and home conditions, but the storage of Augmentin suspension at home conditions (25ºC). showed that the  clavulanic acid rapidly exposed to degradation directly after reconstitution of all batches after 3 days, the assay test were out the limit, however, when stored at refrigerator temperature (2-8ºC) the degradation of clavulanic acid is very low after prolong period (about 10 days). The results of amoxicillin concentration in all tested batches that were stored at 2-8ºC were very similar to the results of assay that were stored at room temperature. Key words: stability evaluation, amoxicillin, clavulanic acid, degradation, reconstitution.

This study investigates the stability of paracetamol pediatric oral suspension (120mg/5ml) in simulated in-home storage conditions at temperature ranging from (2-8C0) representing refrigerator condition. Samples from suspension were assayed and tested for related substance (degradants) using B.P pharmacopeia HPLC method. The study was performed in day zero, seven, fourteen, thirty and forty five.  The instrument employs column ® C8, 100 x 4.6 mm, 3.5 μm particle size. The mobile phase consisted of methanol, tetrabutylammonium hydroxide (40 %) and sodium orthophosphate buffer. The results showed that the drug assay content remains within the limits up to day fourteen. Furthermore, the half live was found to be 36.8 days.

Iloperidone is a novel antipsychotic drug widely used to treat schizophrenia. Objective of this investigation was to develop a validated stability indicating high performance thin layer chromatographic method for the quantification of iloperidone in bulk and pharmaceutical dosage form. Aluminium backed TLC plates precoated with silica gel 60F-254 was employed as the stationary phase and n-propanol: chloroform (5:5 v/v) as the mobile phase. Densitometric analysis was performed at 275 nm in the reflectance mode. Compact spots of iloperidone with Rf value 0.36 were observed. Validation of the method as per ICH guidelines produced satisfactory results of linearity (r2>0.999), limit of detection (5.349 ng/spot), limit of quantification (16.2099 ng/spot), precision (< 2%), and accuracy (99.66 ±0.341 to 100.34±0.292%). Degradation products were found to be well separated from the pure drug with significantly different Rf values suggesting a stability indicating analysis method for the estimation of iloperidone in pharmaceutical preparations and as bulk drug. The proposed method is selective, sensitive, precise, and accurate. It is also simple, economic and time saving as compared to reported HPLC methods.