Stability Indicating UV Spectrophotometric Method for Estimation of Omeprazole and Its Application to Content Uniformity Testing

Author(s):  
Biju V M ◽  
Naga Gayatri S ◽  
Meenu P M

Omeprazole is a most commonly used antiulcer agent in clinical practices. A least time consuming efficient and simple ultraviolet spectrophotometric method for the assay of omeprazole has been developed. The assay was based on the ultraviolet absorbance maxima at about 217.80 nm wavelength of omeprazole using sodium hydroxide as the solvent. In the present study comprehensive stress degradation was carried out according to ICH Q1 (R2) guidelines. The drug was subjected to acidic (0.1N HCl), basic (0.1N NaOH), oxidative (1% H2O2), photolytic and thermal degradation conditions. The developed UV spectrophotometric method showed high degradation under acidic condition, moderate degradation under basic, photolytic and thermal conditions. But it was relatively stable under oxidative conditions. The pathway for degradation has been proposed. The method was validated for Linearity, Accuracy, Precision, Specificity, Ruggedness and Robustness. The method shows good linearity in the range of 2-20μg/ml. The LOD and LOQ were found to be 0.1 μg/ml and 1.1 μg/ml. The %RSD was found to be with in limit i.e. less than 2%.The mean recovery of placebo was 100.68%. It can be concluded that the developed procedure is valid and can be applicable for determination of content uniformity for available brands of omeprazole. This method is applicable for the daily routine quality control quantitative analysis of omeprazole.

1988 ◽  
Vol 71 (6) ◽  
pp. 1121-1122
Author(s):  
Barry Mopper

Abstract A UV spectrophotometric method for the determination of hydralazine hydrochloride in tablets was collaboratively studied by 5 laboratories. The method is based on conversion of hydralazine to a tetrazolo [5,l-a]phthalazine derivative which shows an absorption maximum at about 274 nm. Each collaborator received blind duplicate samples of 2 commercial powdered composites from 10 and 100 mg tablets, and 1 synthetic tablet formulation. Each collaborator also received a set of 10 tablets for determination of content uniformity. The pooled mean recovery of hydralazine hydrochloride from the synthetic formulation was 101.2 ± 0.94%. The mean assay values for 10 and 100 mg tablets were 95.6 ± 0.98 and 101.0 ± 0.73% of the declared amounts, respectively, with corresponding CV values of 1.02 and 0.73%. The pooled mean for individual tablet assay was 99.8 ± 3.26% of the declared value, with a CV of 3.29%. The method has been adopted official first action


1982 ◽  
Vol 28 (1) ◽  
pp. 96-99 ◽  
Author(s):  
O Wålinder ◽  
G Ronquist ◽  
P J Fager

Abstract We compared a spectrophotometric kit method (Glycospec) for determination of glycosylated hemoglobin (HbA1) with a microcolumn kit method (Bio-Rad). The Glycospec method is based on the change in absorbance when phytic acid binds to hemoglobin A. With glycosylated hemoglobin there is no such change because the binding is blocked by the sugar moiety. Inter-assay CVs were 2-6% for both methods. In healthy subjects the mean (+/- SD) value for HbAl was about 1% higher with the spectrophotometric than the microcolumn method. For samples from 122 diabetics the correlation between values for HbAl obtained with the two methods was acceptable (r = 0.89), although the spectrophotometric technique yielded 2-4% higher values, a difference at least partly due to the absence of 2,3-diphosphoglycerate from the spectrophotometric standards. Adding 1.8 mmol of it per liter to these standards caused displacement of the standard curve; HbAl values then agreed well with those of the microcolumn method. The spectrophotometric procedure is easily automated, and therefore is well suited for large-scale analyses if problems with standards and calibration can be solved.


1969 ◽  
Vol 15 (9) ◽  
pp. 884-890 ◽  
Author(s):  
Nickie L Nicholas ◽  
Harold Brown ◽  
Anna M Swander

Abstract A clinically useful spectrophotometric method for the determination of 3-methoxy-4-hydroxyphenylglycol (MHPG) is presented. After treatment with barium chloride, the urine is hydrolyzed with Glusulase (β-glucuronidase and sulfatase).† The hydrolysate is passed through a column of Amberlite CG-4B‡ to remove any 3-methoxy-4-hydroxymandelic acid (MHMA) and the pH is adjusted to neutral. The MHPG is extracted with ethyl acetate and returned into potassium carbonate solution. Conversion of the MHPG to vanillin is accomplished with periodate and the vanillin is subsequently extracted with toluene and then potassium carbonate solution. The vanillin concentration is determined at 360 nm and 380 nm. The mean recovery of added MHPG standard was 54.9%. The mean daily excretion of MHPG in 23 samples from 10 normal subjects was 1.87 ± 0.6 mg (range 0.81-3.64). In 3 subjects with pheochromocytoma the excretion of MHPG was markedly elevated. There was an excellent correlation of the MHMA and MHPG excretion.


2011 ◽  
Vol 5 (2) ◽  
pp. 217-224 ◽  
Author(s):  
Manel Araoud ◽  
Fadoua Neffeti ◽  
Wahiba Douki ◽  
Abderraouf Kenani ◽  
Mohamed Fadhel Najjar

Abstract Background: Human plasma paraoxonase1 (PON1) is an esterase catalyzing the hydrolysis of organophosphorus pesticides and other xenobiotics. The aims of this study were to develop a rapid method to determinate PON1 activity, evaluate some interference, and study the influence of storage temperature on PON1 activity assay. Methods: Measurement of PON1 activity was performed for 369 samples by measuring the hydrolysis of paraoxon using a spectrophotometric method adapted on konelab 30 ⃞. Results: The developed method facilitates the determination of PON1 activity at the rate of more than 200 samples per hour, and it is linear between 2 and 900 IU/L. Intra and inter-assay imprecision coefficients of variation were 2% and 5% respectively. PON1 activity in serum was correlated with those in heparinized plasma (r = 0.994, p < 0.001) and in plasma/EDTA (r = 0.962, p < 0.001). The mean inhibition of the PON1 activity was, by EDTA/K3, 41 ± 10 %. There was not significant PON1 activity variation after 40 days of storage at -20°C or at +4 ⃞ C. There were no substantial interferences from haemoglobin, jaundice and hyperlipidemia. Conclusion: The developed method is reliable, reproducible, and suitable. It can also be performed on heparinized plasma for the determination of PON1 activity. Hence, it may be useful for assaying PON1 activity in several intoxications such as organophosphorus, sarin, and soman nerve agents.


1987 ◽  
Vol 70 (1) ◽  
pp. 42-46
Author(s):  
Barry Mopper

Abstract Routine use of the USP XXI spectrophotometric method for the content uniformity determination of hydralazine hydrochloride tablets has shown that tablet excipients can significantly alter the spectral characteristics of the drug and thus cause inaccurate assay values to be obtained. Because of this problem, a simple and reliable alternative spectrophotometric assay method, based on the conversion of hydralazine to tetrazolo [5,l-α]phthalazine with nitrite ions under acidic conditions, was developed. The derivative showed an absorption maximum at about 274 nm and obeyed Beer's law over the concentration range 4-40 μg/mL. Mean recoveries of hydralazine hydrochloride added to commercial coated and uncoated tablets were 101.0% (n = 10) and 100.8% (n = 8), respectively. The proposed method was found suitable for the assay not only of individual tablets but also of tablet composites


1978 ◽  
Vol 61 (2) ◽  
pp. 296-298
Author(s):  
Mark A Litchman

Abstract The spectrophotometric method for pyrantel tartrate in swine feeds was collaboratively studied. Twenty-seven laboratories assayed feeds containing 0.0103, 0.0965, and 0.7902% pyrantel tartrate. Repeatability (σo) and reproducibility (ax) standard deviations were: σo = 0.00068%, σx = 0.00105% (10% of grand mean) for 0.0103% pyrantel tartrate level; σo = 0.0065%, σx = 0.0090% (10% of grand mean) for 0.0965% pyrantel tartrate level; and σo = 0.0415%, σx = 0.0743% (10% of grand mean) for 0.7902% pyrantel tartrate level. The mean theoretical recovery values for feeds containing 0.0103, 0.0965, and 0.7902% were 100, 97, and 96%, respectively. The method was adopted as official first action for feeds or concentrates containing 0.0106–0.8811% pyrantel tartrate.


Author(s):  
Nief Rahman Ahmed ◽  

A simple, economical and sensitive UV spectrophotometric method has been developed for the determination of allopurinol in environmental wastewater samples and, pharmaceutical preparations which shows maximum absorbance at 250 nm in distilled water. Beer’s law was obeyed in the range of 1 - 20 μg/ ml, with molar absorptive of 0.628 x104 l/mol.cm L.mol-1.cm-1 .The method was successfully applied to the determination of allopurinol in some pharmaceutical formulations (tablets) and industrial wastewater samples. The proposed method was validated by sensitivity and precision which proves suitability for the routine analysis of allopurinol in true samples.


2016 ◽  
Vol 1 (1) ◽  
pp. 36 ◽  
Author(s):  
Neelam Devi ◽  
Sunil Kumar ◽  
Sunny Rajan ◽  
Jagbir Gegoria ◽  
Sheefali Mahant ◽  
...  

Clobetasol 17-propionate is used most potent topical glucocorticoid clinical effective in treatment of topical dermatitis, vitiligo and psoriasis. A rapid, simple, selective and precise UV- Visible Spectrophotometric method has been developed for the determination of Clobetasol 17-Propionate (CP) in bulk forms and dosage formulations. The spectrophotometric detection was carried out at an absorption maximum of 239 nm using ethanol as solvent. The method was validated for specificity, linearity, accuracy, precision, and robustness. The detector response for the CP was linear over the selected concentration range 2 to 40μg/ml with a correlation coefficient of 0.9999. The accuracy was between 99.1 and 101.4 %. The precision of 4μg/ml sample preparation three times in a day (intraday) was 0.1325%. The Limit of Detection (LOD) and Limit of Quantification (LOQ) are 0.84 and 2.55μg/ml, respectively. The recovery of CP was about 101.84%. The results demonstrated that the excipients in the commercial formulation did not interfere with the method and can be conveniently employed for daily routine quality control analysis of CP in bulk drug, marketed formulations.


Author(s):  
Nita Yadav ◽  
Anju Goyal

Objective: In the present research work three simple, accurate, precise methods of the UV-visible spectrophotometric method was developed and validated for the estimation of Vilazodone HCl in bulk and tablet dosage.Methods: Three methods were used for estimation of Vilazodone HCl using methanol. Method A involves zero order spectroscopy at absorption maximum of 241 nm; Method B involves first order derivative at 246.5 nm and Method C involves second-order derivative at 243.5 nm. The developed methods were validated according to ICH guidelines.Results: The developed methods were found to be linear in the concentration range of 1-5 µg/ml. The mean percentage label claim of Vilazodone HCl was within the acceptable range. The accuracy data showed % recovery and % RSD within the range.Conclusion: The developed methods were found to be accurate and precise. The % RSD values were within limits. These methods can be used for the routine analysis of Vilazodone HCl in bulk and tablet dosage form.


2003 ◽  
Vol 86 (6) ◽  
pp. 1144-1148
Author(s):  
Thomas M Primus ◽  
Dennis J Kohler ◽  
Margaret A Goodall ◽  
Christi Yoder ◽  
Thomas Mathies ◽  
...  

Abstract 4, 4'-Dinitrocarbanilide (DNC) was extracted from chicken, duck, goose, and snake eggs and isolated by reversed-phase liquid chromatography. DNC was detected by ultraviolet absorbance at 347 nm and quantitated by comparison with a calibration standard. Recoveries of DNC from fortified control chicken, duck, goose, and snake egg samples were determined for DNC levels of 0.16, 10, and 16 μg/g. The mean recoveries from chicken, duck, goose, and snake eggs were 92 ± 4, 88 ± 9, 87 ± 7, and 95 ± 6%, respectively. The method limits of detection for DNC in chicken, duck, goose, and snake eggs ranged from 0.015 to 0.035 μg/g. The reported method is much simpler than and equally efficient as previous methods developed for the determination of DNC residues in egg contents.


Sign in / Sign up

Export Citation Format

Share Document