Stability Testing of Nifedeipine

Stability Testing of NifedeipineSyed Masood Hassan AkbariPractical 2 Stability register of NifedipineINTRODUCTIONNifedipine is considered as a proto eccentric coalesce of the dihy scratch offyridine class of calcium channel antagonists. Nifedipine is a selective arterial dilator, and also is use in the treatment of hypertension, angina and cardiovascular dis places. The drawback associated with nifedipine is that it female genital organ undergo photo adulteration thus escalating in harm of pharmacological activity. This process involves the reduction of the aromatic nitro group to nitroso group or the oxidation of the dihydropyridine ring to a pyridine ring. Nifedipine synthesizers make use of barge revolting coating to reduce their photo humiliation. It has been found out that overdue to poor storage conditions the clinical efficacy of nifedipine can drop drastically. In rule to fix this a selection of ingredients within the dot form can be altered or enhanced in order to minimise photosensitivity. Ion-ex commute beads be self-colored and suitably are high molecular weight polyelectrolytes that can easily exchange their wandering(a) ions of equal charge with neighbouring medium reversibly. The ion-exchange bead can form a complex with nifedipine and its utility used to embrace drug in light natures. Instability of the drug product whitethorn lead to a reduction in the bioavailability of the drug. It is also highly important that the patients do ask for their uniform does of the drug throughout the whole of the shelf life of the product.This audition goes through the photodecomposition kinetics of nifedipine at zero-order when the reception commences. As the reaction proceeds further to 50% the kinetics of the reaction changes to outset-order. figure of speech 1 Represents nifedipine degradation at the two different wavelengths shown above.This es arrange consisted of 3 main comp integrityntsDetermining the stability of nifedipine use HPLC at versatile time intervals.Estimating the half-life for the disappearing drug.Examining the relative stability of the drug as demolish and in solving.EXPERIMENTALFor HPLC20mg of nifedipine was weighed out and placed in a 100ml volumetric flask use the mobile phase to elucidate up the flask. The resulting solutions colouring was noted and transferred to a beaker and covered with paraffin. A polished insertion was made to take up 2ml of the solution into an injection using a 0.2m filter. The time was noted and the judge was loaded and feast immediately and the beaker was covered with paraffin and placed on a shelf where sunlight was present and after every 15 min intervals the hear was injected into the apparatus and it was run. After each run was carried out the peak range for each of the runs were recorded.For stability in solid form100mg of the solid sample of nifedipine was weighed out in a weighing boat and interruption out evenly and placed on a window ledge with prim Irish sunlight for a duration of 2 hours. The show was noted before and after the time lapsed. The solid sample was because homogenised and 20mg was taken and placed in a 100ml volumetric flask and made up to the mark with the mobile phase. Straight away 2ml solution was taken and placed on a 0.2m filter and was vigorous for injection. The peak area of the solid sample was recorded in the report.RESULTS CONCLUSIONS purpose of the stability of nifedipine solid and liquid samples with sunlight.Table 1 Shows the nifedipine run time with 15 here and now intervals, the solid form and a UV sample.The illustrations below show the HPLC peaks at various time intervals with their retentivity times, peak area and heights.Figure 2 Depicts nifedipine at T0.Figure 3 Depicts nifedipine at T20.Figure 4 Depicts nifedipine at T35.Figure 5 Depicts nifedipine at T50.Figure 6 Depicts nifedipine at T65.Figure 7 Depicts nifedipine at T80.Figure 8 Depicts nifedipine at T95.Figure 9 Represents the peak area plan against time of nifedipine degradation taken at 15 minute intervals.After carrying out the experiment it can be said feeling at the data that the reaction kinetics are of zero order at least from T0-T80. At T95 it is seen that the peak gets a bit considerable it can show that a new peak is starting to form, it the experiment had continued for at least 45 minutes more then it could have been the start of the first order reaction kinetics. Therefore it can be deduced that according to the data come through the reaction kinetics are still at zero order during data acquisition.From the graph using the equation y = a + bxb = slope = -12046.1 +/- 841.833The half-life of nifedipine was found using the equationAs we were dealing with zero order kinetics so, r = kUsing, t1/2 = In(2)/kt1/2 = 0.693/0.988t1/2 = 0.701According to the data gathered it is seen that the solid sample of nifedipine resembles to the first T0 liquid sample. By this reflectivity a person can say that the solid state sample did not show any signs of degradation after the 2 hour window. The colour of the liquid samples were changing from discolour at T0 to worn down yellow(a) at T80. On the other kick in for the solid sample from the light yellow powder after the 2 hour window a layer of dark yellow powder was seen and the powder was mixed around and it was seen the underlying solid particles still contain the same colour of light yellow. According to the UV data at T0 and max of 334 it generated an absorbance of 0.604. Whereas for the T100 with a max of 279 generated an absorbance of 1.064.QUESTIONSComment on the relative photostability of solid and solution nifedipine in daylight.The solid sample of nifedipine after being expose to 2 hours of Irish sunlight visual observation showed a darker colour change from light yellow to a darker scarce when the powder was mixed the underlying layer was of the same light colouration as it started with. And after the 2 hours windo w the HPLC result showed no degradation at all. This could be due to the practical being carried out in doors and the lack of the photons getting to the solid sample.On the other hand in the liquid sample things were not much better from a yellow solution starting at T0 T80 there was no colour change but after performing the next HPLC the colour had gone faint yellow. If the apparatus would have been given 45 minute more the results attained would be of first order kinetics. As it stands it is zero order kinetics.What type of reaction is the nifedipine decomposition?ReductionWhat other decomposition reactions do you mobilise nifedipine might undergo?OxidationWhat are the implications of your observations for the proper handling and storage of nifedipine?Manufacturers of nifedipine products use light resistant coating or packing to minimize their photodegradation. Long term pictorial matter to sunlight or artificial light may also go along if nifedipine formulations are inappropr iately stored by patients. Poor storage conditions may potentially decrease clinical efficacy of nifedipine.What validation do you think might be important in the type of analysis you performed straightaway?Validation of an analytical method is the process that establishes by laboratory studies, that the exercise characteristics of the method meet the requirements for the intended analytical applications.The typical analytical characteristics used in method validation vary but the relevant one for this experiment is stability, system suitability and system sensitivity.Prepared sample/ streamer stability is defined as the ability of the analyte to remain stable in the diluent at the test concentration specified in the analytical method.System suitability testing is an entire part of many analytical procedures. The tests are based on the concept that the samples to be analysed constitute an integral system that can be evaluated as such. System suitability is hardened by various m ethods. Any one or a crew of the following may be written into the method as necessary for using the method for routine post validationResolution ensures that virtually eluting compounds are resolved from each other and establishes the resolving power of the system. It contains as close as is possible to a complete sample matrix. in the long run capacity factor is a measure of the time the solute spends in the stationary phase relative to the time it spends in the mobile phase.