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Home > Pharmaceutical Evaluation of Metronidazole Tablet With Hplc Method Validation

Pharmaceutical Evaluation of Metronidazole Tablet With Hplc Method Validation

Thesis Info

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Author

Kashif Ali Safdar

Program

PhD

Institute

University of Karachi

City

Karachi

Province

Sindh

Country

Pakistan

Thesis Completing Year

2015

Thesis Completion Status

Completed

Subject

Pharmaceutics

Language

English

Link

http://prr.hec.gov.pk/jspui/bitstream/123456789/13499/1/Kashif_Ali_Safdar_Pharmaceutics_2015_HSR_UoK_Karachi_02.01.2017.pdf

Added

2021-02-17 19:49:13

Modified

2024-03-24 20:25:49

ARI ID

1676726865480

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The choice of an analytical method is usually governed by the intrinsic analytical properties of the drug molecule or its amenability to chemical derivatisation to render it compatible to quantitation. The reliability of the quantitation depends on these analytical techniques. Currently, reversed phase high–performance liquid chromatography with UV detection represents the analytical method of choice for the quantitative determination of raw material, in-processes formulation, finished products as well as in the biological matrix. Metronidazole is one of the most effective and clinically very useful and popular antibacterial agent which also possess antiprotozoal action. The clinical importance of these agent is continuously increasing with the passage of time, as the infections are caused by the different pathogens/microorganisms. In the proposed study first developed the analytical method for the determination of metronidazole then validate it for the evaluation of pharmaceutical property of different brands of metronidazole 200mg and 400mg available in the local market as per ICH guideline. The parameters that used for the validation were specificity, linearity, accuracy, precision, lower limit of detection, quantitation and stability of drug in mobile phase as well as in biological matrix. The mobile phase was comprised of 0.01 molar potassium dihydrogen phosphate buffered at pH 3.0 and acetonitrile in ratio of 83: 17. The drug was eluted from C18 column (5µm; 250 mm X 4.6 mm). The % RSD of peak areas of metronidazole was 0.03% and the mean retention time of six consecutive injections was 5.333 minutes. The LOD and LOQ of the method was 8.14ng/mL and 32.56ng/mL respectively. The drug was stable in mobile phase as well as in plasma up to 28 days that shows the method can be used successfully not only for the raw material and finished product but also for pharmacokinetic study in human. A new formulation (ODT) was developed with the use of different super disintegrants such as sodium bicarbonate and crospovidone. Comparison of disintegration and friability of the tablets showed that the tablet with crospovidone is more close to our objective. The optimization study was performed with the aid of software “DesignExpert 9.0.1, State Ease Inc.” The amount of crospovidone and HPMC per batch were taken as independent variable to assess their effect on the disintegration time and friability of the formulation. Central composite design was selected for optimization process and number of batches were prepared. The amount of X1 (Crospovidone) and X2 (HPMC) predicted by the software with the desirability of 1.0 were 37.76mg and 16.71mg respectively. A check point batch were prepared based on these predicted amounts to confirm the validity of the design for this optimization process. The results revealed that by increasing the concentration of crospovidone in formulation decreases disintegration time of tablets which is quite expected as it enhances the wicking property of the formulation. Similarly, it was also observed that increase in concentration of HPMC significantly decreases the % friability of the tablets as it improves the cohesive binding forces. The check point batch was subjected to stability studies after blistering for 06 months. All the tests performed as per USP for the physicochemical and stability evaluation periodically at time interval of 3 months and 6 months. The results were then compared with the initial results to evaluate the stability characteristics of the formulation. The results showed no significant differences at time intervals of 0, 3 and 6 months. Hence the formulation found to be well stable under the recommended conditions (temperature: 40 ± 2°C & % RH: 75 ± 5%). The friability was between 0.47% - 0.50%, disintegration time was between 15 – 16 seconds and in vitro dissolution at three different time intervals i.e. 0, 3 and 6 months were between 98.08 - 98.29% during the entire period of stability studies. No significant variation observed in content assay of stability batch throughout the study period. The CDP of metronidazole 200mg, 400mg brands and formulated tablets were performed in three dissolution mediums i.e. pH 1.2 buffer, pH 4.5 buffer & pH 6.8 buffer. The samples were withdrawn at different time intervals i.e. at 10, 15, 20 and 30 minutes and absorbance was taken at λmax 278.0 nm. Percent dissolution calculated with the help of Microsoft excel add-in “DD Solver” v1.0 found to be ≥ 85% within 15 minutes which indicates that dissolution is not a rate limiting step in the bioavailability of these tablets. Different dissolution models were also applied to verify the drug release pattern between the marketed and formulated drug and it was found that the pattern release of the formulated tablets is same as that of the marketed and innovator brands
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"ہم نے یہ کتاب تم پر نازل کر دی ہے جو ہر چیز کی صاف صاف وضاحت کرنے والی ہے اور ہدایت و رحمت اور بشارت ہے اُن لوگوں کے لیے جنہوں نے سر تسلیم خم کر دیا ہے" ۔

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Assessing the Environmental Literacy of Secondary School Teachers in Punjab

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