Comparative In Vitro Quality Evaluation of Some Clopidogrel Tablets, Commercially Available in Bangladesh Drug Market (original) (raw)
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Comparative Evaluation of Some Commercial Clopidogrel Tablets Available in Yemen
Majalah Farmaseutik
Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration t...
Comparative Evaluation of Some Commercial Clopidog
Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration times as they disintegrated within 15 minutes. In case of dissolution profile, all brands except C6 showed acceptable dissolution time as they released more than 60% of drug in 45 minute. The hardness of only two brands was within the range. All brands also meet the potency specifications. This study suggested that most commercially Clopidogrel tablets in Yemen maintain the quality and comply with the pharmacopeia specifications.
Validated Stability Indicating HPTLC of Clopidogrel and its Pharmaceutical Formulations
International Journal of Scientific Research in Science, Engineering and Technology, 2019
The present paper describes stability indicating high-performance thin-layer chromatography (HPTLC) assay method for clopidogrel in bulk drugs. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: triethylamine (6.5: 4.0: 0.1 v/v/v). The system was found to give compact spot for Clopidogrel (Rfvalue of 0.40 ± 0.010). Densitometric analysis of Clopidogrel was carried out in the absorbance mode at 254 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.999 with respect to peak area in the concentration range 30 - 120 ng/spot. The developed HPTLC method was validated with respect to accuracy, precision, recovery and robustness. Also to determine related substance and assay determination of Clopidogrel that can be used to evaluate the quality of regular production samples. The developed method can also be conveniently used for the as...
Formulation Development and Evaluation of Clopidogrel Fast Dissolving Tablets
The main objective of the present research work is to formulate the Clopidogrel Fast Dissolving tablets. Clopidogrel, an antiplatelet drug, belongs to BCS Class-II and used to control Heart attack, Hypertension by inhibiting Platelet activation and aggregation .The Fast Dissolving tablets of Clopidogrel were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrant by Direct Compression technique using 3 2 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X 1 and X 2 respectively whereas, wetting time, Disintegration time, t 50% , t 90% were selected as dependent variables. Totally nine formulations were designed and evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, and in-vitro drug release. From the Results it was concluded that all the formulation were found to be with in the Pharmacopoeial limits and the in-vitro dissolution profiles of all formulations were fitted into different Kinetic models, the statistical parameters like intercept (a), slope (b) and regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t 50% , t 90%. Validity of developed polynomial equations was verified by designing 2 check point formulations (C 1 , C 2). According to SUPAC guidelines, the formulation (F 5) containing combination of 15% Crospovidone and 15% Croscarmellose, is the most similar formulation (similarity factor f 2 =91.3936, dissimilarity factor f 1 = 1.203& No significant difference, t=-0.00062) to marketed product (PLAVIX-75). The selected formulation (F 1) follows First order, Higuchi's kinetics, mechanism of drug release found to be Fickian Diffusion (n= 0.226).
Indo American Journal of Pharmaceutical Research, 2013
The main objective of the present study is to enable the prediction of in vivo performance of clopidogrel extended release mini-tablets in capsule by simulated In vitro bio relevant dissolution testing method. The optimized formulation evaluated for dissolution at different agitation speed shown, no significant difference in dissolution profile and the F2 value observed was 96 & 88 at 75 RPM & 125RRPM respectively in comparison to 100RPM. The formulation evaluated for dissolution under simulated pre-prandial condition and post-prandial conditions using USP dissolution apparatus -3, resulted the extent of dissolution of 82.3% and 91.5% respectively at 12 hours. A pharmacokinetic study conducted with clopidogrel extended release mini tablets, on rabbits under pre-prandial condition was deconvulted to fraction of drug absorbed, and compared for IVIV–level A correlation. The result reveals good correlations between in-vitro drug release and in-vivo drug absorption in pre-prandial state, and the F2 value observed was 73.
Formulation and evaluation of orally disintegrating clopidogrel tablets
Brazilian Journal of Pharmaceutical Sciences, 2016
Recent advances in drug delivery systems have aimed to achieve better patient compliance. One of these advances is the formulation of orally disintegrating tablets (ODTs) that dissolve instantaneously, releasing drugs within a few seconds without the need of water. The main objective of this paper was to prepare and develop ODTs of clopidogrel. The ODTs were prepared by direct compression. The effect of three superdisintegrants, namely crospovidone, croscarmellose sodium, and sodium starch glycolate, using three different disintegration times on the dissolution rate was investigated. The prepared tablets were evaluated for hardness, friability, disintegration time and in vitro drug release. Furthermore, the interaction of clopidogrel with the formulation excipients was studied using differential scanning calorimetry (DSC). DSC studies revealed that there were no interactions between the drug and the excipients used. All tablets had hardness values in the range 4.0-5.2 kp and friabil...
2017
Different formulations were made with an aim to develop stable, cost effective Clopidogrel tablets by direct compression technique. Four formulations (F1 – F4) having Primojel and xanthan gum at different concentrations level were prepared. The prepared batches of tablets were evaluated for hardness, friability, disintegration and in-vitro dissolution study. All The formulations containing combination of Primojel and Xanthan gum showed different in-vitro disintegration time and drug release.
QUALITY CONTROL TESTING OF CONVENTIONAL CLOPIDOGREL BISULFATE TABLETS MARKETED IN IRAQ
International Journal of Applied Pharmaceutics, 2022
Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia.
Journal of Taibah University for Science, 2014
A novel, simple, economical reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for quantifying clopidogrel in bulk and tablet form with greater precision and accuracy. Separation was achieved on a Develosil ODS HG-5 RP C 18 (15 cm × 4.6 mm, i.d. 5 m) column in isocratic mode with a mobile phase consisting of acetonitrile:phosphate (65:35) buffer (pH 2.85) with a flow rate of 1 mL/min. Detection was carried out at 225 nm. The retention time of clopidogrel was 7.48 min. The method was validated as per the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Linearity was established for clopidogrel in the range 10-60 g/mL, with an r 2 value of 0.999. The recovery of clopidogrel was 99.71-100.03%. The high recovery and low relative standard deviation confirm the suitability of the proposed method for estimating the concentrations of the drug in bulk and tablet dosage forms. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible for the determination of clopidogrel for quality control.