Current Issue : January - March Volume : 2011 Issue Number : 1 Articles : 10 Articles
The total annual Indian Chyawanprash market is estimated to be around INR 250 crore that is now growing double-digit with the entry of more players, and variants such as sugar-free and stress busters, giving it a makeover. But in all these cases Ghee is an essential ingredient which is required to fry the Amla pulp during the manufacturing of Chyawanprash. The amount of cholesterol present in Chyawanprash is depended on the quality & quantity of ghee used. So the present investigation was carried out for the estimation of cholesterol in ten assorted brands of Chyawanprash which were most commonly available in the local market of Jaipur Rajasthan reveals varying levels of cholesterol content. Cholesterol estimation was evaluated spectrophotometrically by Liberman-Burchard method at 640 nm. The results of this studies indicates that all investigated brands of Chyawanprash showed percentage cholesterol content significantly higher (P<0.05) as compared to standard sample S1 (0.0276 ±0.004)....
To develop a simple, rapid, accurate, precise and reproducible reversed phase high performance liquid chromatographic method has been developed for the estimation of levofloxacin in bulk and in tablets. Development of a method for the determination of levofloxacin, an antibacterial agent, by RP-HPLC was undertaken using a new mobile phase of phosphate buffer:acetonitrile (40:60, v/v). The eluent was monitored at 295 nm. The optimized conditions developed showed a linear response from 10 to 50 μg/mL, with a correlation coefficient of 1.000. The retention time of the drug was found to be 2.675 min. The limit of detection (LOD) and limit of quantification (LOQ) were 0.015 and 0.051 μg/mL, respectively. The assay values for the two branded levofloxacin tablets tested were 100.0 and 98.2 %, respectively with % relative standard deviation (RSD) of 1.01 and 0.89, respectively. Recovery data were good. Placebo study for specificity and interference of common excipients showed that the method was specific and free from interfering substances. Therefore, the fully validated method developed was sensitive enough to carry out analysis of levofloxacin in tablet formulations with regard to its run time, simplicity of sample preparation and accuracy. The proposed method was statistically evaluated and can be applied for routine quality control analysis of levofloxacin in tablets....
A novel High performance liquid chromatography (HPLC) method for analysis of formoterol in dry powder inhaler has been developed and validated. A formulation containing formoterol and a carrier lactose with a target concentration of formoterol blend 0.266 % w/w was prepared and filled in an Airmax NB7/2 inhaler followed by pharmaceutical performance testing and analysed by HPLC with electrochemical detection. The validationand pharmaceutical performance testing was performed by FDA and ICH regulations for the validation of pharmaceutical samples. The samples were injected onto a reverse phase waters symmetry column maintained at 30 ⁰ C. The mobile phase consisted of potassium di-hydrogen orthophosphate buffer: acetonitrile (79:21, V/V) and the formoterol peak was detected at the following detector settings on the Decade digital electrochemical detector (ECD). Detector settings: working electrode potential (Eox): 0.65 V, Guard cell potential ( E twin ) : 0.70 V. Range select: nano amps, Range: 50 nano amps, Offset: 20%, Filter: 0.1 seconds. The mean blend strength was 0.269 % w/w. Recovery 101.1% and the blend homogeneity (RSD) / % was 0.9. The uniformity of the delivered dose for 6 µg product was DPA/µg: 5.6 ±0.5 and for 12 µg product was DPA/µg : 11.3 ± 08. The fine particle dose for 6 µg product was FPD/µg: 2.4 ± 0.1 and for 12 µg product was FPD/µg: 4.7 ± 0.2. The calibration curve was linear ( r2= 0.9968) over formoterol concentrations ranging from 0.1 to 0.7 µg/ml (n=7). Intra and inter day relative standard deviation (RSD) of variation between 0.3 and 4.1 and accuracy percentage recovery was between 92-108 %. Formoterol was stable over 3 day’s precision. Limit of quantification was 0.1 µg/ml and the limit of detection was 0.0625 µg/ml. The method is selective, reproducible and even though the linearity range is 0.1 µg/ml to 0.7 µg/ml the method has the capacity to be used for determination of formoterol in dry powder inhaler....
A simple, precise and rapid high-performance thin layer chromatography method is developed and validated for analysis of tizanidine in plasma. Following liquid-liquid extraction, the analytes are separated using toluene: acetone: ammonia (6:6:0.4 v/v/v) as a mobile phase on Merck HPTLC aluminium backed sheets of silica gel 60 F254 and scanned at 254 nm using densitometer. The linearity of tizanidine (r2=0.991±0.001) in plasma is found in range of 300–1100 ng/spot. Standard curve concentration range shows acceptable precision and accuracy. Method is validated according to I.C.H. and U.S.F.D.A. guidelines. Intraday and interday precision is less than 15 % R.S.D. while average % recovery is found to be 99.72 with average % R.S.D. 0.4865. Statistical analysis suggests that the method is repeatable and selective for estimation of tizanidine in plasma. This method could effectively analyze tizanidine in plasma hence can be employed for application in pharmacokinetic, bioavailability or bioequivalence studies....
The tubers of Dicentra paucinervia, a highly potent ethno medicinal herb, have been used by tribals living in the eastern Nagaland and adjoining Manipur states of India in the treatment against various diseases. The plant was also grown in Dehradun to examine its adaptability and utilization in the Uttarakhand state. Allocryptopine was one of the major alkaloid constituents found in the tubers of the plant. The content of allocryptopine was determined in the tubers of the plants grown in Manipur and Dehradun. HPTLC method was first validated using pure allocryptopine and applied for its quantittaion in the tubers. The method validation was comprised of (i) chromatographic conditions, (ii) linearity, (iii) precision, and (iv) recovery experiments. The method was found to be simple, rapid and accurate for quantification of allocryptopine in the tubers of Dicentra paucinervia. The allocryptopine content was determined to be 0.69% (Manipur) and 0.70% (Dehradun)....
Quantitative estimation of poorly water-soluble drugs involves use of organic solvents. Major drawbacks of organic solvents include high cost, volatiliy and toxicity. In the present investigation, hydrotropic solubilization is employed to enhance the aqueous solubilities of poorly water-soluble drugs tinidazole and ofloxacin in two-component tablet formulation for simultaneous spectrophotometric determination. Three simple, accurate and economical procedures employed are simultaneous equation method, absorbance ratio method and dual wavelength method. All methods utilize 8.0M-urea solution as, hydrotropic solubilizing agent. In the urea solution, tinidazole and ofloxacin show maximum absorbance at a wavelength of about 319 and 288nm respectively and isobestic point is observed at 301nm. The hydrotropic agent and additives used in the manufacture of tablets did not interfere in the analysis. The results of analysis have been validated statistically and by recovery studies....
Two simple, sensitive and accurate methods have been developed for the quantitative analysis of prulifloxacin in its pure and pharmaceutical formulations. The proposed methods were based on formation of a yellow coloured drug-dye complex that has resulted from the reaction of prulifloxacin and bromothymol blue (method-I) and the formation of blue coloured complex resulting from the reaction of prulifloxacin with 4, 7-diphenyl-1, 10-phenanthroline (Method-II). These methods have showed the absorption maximum at 420nm and 600nm for method-I and method-II respectively. The proposed methods showed good linearity in the concentration range of 5-25 µg/ml (method-I) and 2-10 µg/ml (method-II). The results of analysis for the proposed methods were validated statistically by recovery studies....
The present investigation deals with the development of a new, simple, specific, sensitive, rapid and economical procedure for simultaneous estimation of Dexibuprofen and Paracetamol in bulk and its dosage form. The method is based on the ultraviolet absorbance maxima of the above drugs at 221.5 nm and 246nm wave lengths. These drugs obeyed Beer's Lambert law in the concentration range of 2-14 μg/ml with methanol and phosphate buffer pH 7.4 in 1:1 ratio. The correlation coefficient was 0.9985 and 0.9992 respectively. The proposed method was successfully applied for the simultaneous determination of drug in commercial tablet preparations. The precision and accuracy of the developed method was confirmed by repeatability and recovery studies validated statistically. The LOD of these drugs were found to be 0.0215 and 0.0540 respectively. The LOQ was found to be 0.0651 and 0.1638 for both drugs. The percentage recovery study of the drug for proposed method was found to be in the range of 98.64 – 101.51% w/v for branded drug. The proposed method is recommended for routine analysis since it is rapid, simple, accurate and also sensitive...
Two simple, sensitive and accurate methods have been developed for the quantitative analysis of cinitapride in its pure and pharmaceutical formulations. The proposed methods were based on formation of a violet coloured complex that has resulted from the reaction of diazotized cinitapride and N-(1-naphthyl)ethylenediamne dihydrochloride (method-I) and the formation of yellow coloured molecular salt complex resulting from the reaction of cinitapride with 2,4,6-trinitrophenol (Method-II). These methods have showed the absorption maximum at 525nm and 410 nm and linearity in the concentration range of 4-24 µg/ml and 8-40 µg/ml for method-I and method-II respectively. The results of analysis for the proposed methods were validated statistically by recovery studies....
The present study describes the development and subsequent validation of a stability indicating RP-HPLC method for the estimation of Isoniazid in tablet dosage form. Numerous HPLC conditions were tested for the estimation of Isoniazid. The best result was achieved by using Inertsil ODS 3V (150mm X 4.6mm, 5µ) column, and mobile phase comprising of ammonium acetate adjusted to the pH 5.5 with glacial acetic acid and methanol (90:10) in isocratic mode at a flow rate of 2ml/min at 350C temperature with ultraviolet detection at 240nm. The linear response was observed in the range of 15-90 µg/ml with a correlation coefficient of 0.9995. Accuracy (98.9-99.9%) and precision were found to satisfactorily within limits. The proposed method has adequate specificity for the estimation of Isoniazid in tablet dosage form. The method was proved to be robust with respect to changes in flow rate, column temperature and wavelength. Isoniazid was subjected to stress degradation under different stress conditions like alkali, acid, peroxide and thermal. The simple, sensitive, precise, rapid and specific method was developed and validated statistically for the estimation of Isoniazid in tablet dosage form....
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