DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF MEFENAMIC ACID AND ITS MAJOR IMPURITY 2, 3-XYLIDINE (2, 3-DIMETHYLANILINE)

Author(s):  
Nisha B. Thummar
2016 ◽  
Vol 8 (3) ◽  
pp. 96
Author(s):  
A P Ghugare ◽  
Lalchand Dayanand Devhare ◽  
B P Hatwar

<p>Two simple, rapid, accurate and precise spectrophotometric methods have been developed for simultaneous estimation of Nimorazole and Ofloxacin from tablet dosage form. Method І involves formation of ‘simultaneous equations’ at 304 nm (λ max of Nimorazole) and 287.5 nm (λ max of Ofloxacin); while Method ІІ involves, formation of ‘Absorbance ratio equation’ at 301(isoabsorptive point) and 287.5 nm (λ max of Ofloxacin) using distilled water as a solvent. The linearity was observed in the concentration range of 5 - 25 μg/ml for Nimorazole and 2 - 10 μg/ml for Ofloxacin. The results of analysis have been validated statistically and by recovery studies and were found satisfactory.</p>


2020 ◽  
Vol 16 ◽  
Author(s):  
Mohammad Kashif Iqubal ◽  
Abid Kamal ◽  
Ashif Iqubal ◽  
Mohammad Imran ◽  
Javed Ali ◽  
...  

Background: 5-fluorouracil and resveratrol are the two most effective anticancer drugs. Combination therapy with these two drugs has shown promising results in cancer. The formulation containing 5-fluorouracil and resveratrol has been prepared, but no analytical method is available in the literature for their simultaneous estimation. However, several analytical methods are there for estimation of either 5-fluorouracil or resveratrol alone. Therefore, the present article is designed for the simultaneous estimation of 5-fluorouracil and resveratrol by HPLC and its application in the quantification of the drugs present in the formulated nanostructured lipid carrier (NLC). Methods: The method was developed using a C18 column (Purospher® STAR RP-18 endcapped (5 µm) Hibar® RT 250- 4.6) with acetonitrile and water as the mobile phase (25:75 v/v) and estimated at 272 nm. The currently developed method was further validated by the ICH guideline Q2 (R1). Combinatorial NLC of 5-fluorouracil and resveratrol was also prepared and characterized. Results: The LOD and LOQ were 8.22 and 24.91 µg mL-1 and 6.58 and 19.93 µg mL-1 , respectively. The precisions was under the acceptable limits of < 2% RSD. The content of 5-fluorouracil and resveratrol in NLC were found to be 65.558±1.343% and 96.326±1.421%, respectively. Conclusion: The findings showed that the developed and validated method was simple, fast, cost-effective and reproducible for the simultaneous estimation of both the drugs in the same formulation.


2019 ◽  
Vol 10 (04) ◽  
pp. 583-587
Author(s):  
Venkata Nanda Kumar Kopparapu ◽  
Poornima Kasula ◽  
Ajay Kumar Reddy Ankinapalli ◽  
M Venkateswarlu

Paracetamol (PCT) and Mefenamic acid (MFA), in combination, is recommended widely for the treatment of antipyretic and anti-inflammatory conditions. The present works carry a new simple, rapid, precise, accurate, and sensitized method of high-performance liquid chromatography with UV detection for simultaneous quantification of PCT and MFA. The samples are eluted in isocratic mode using a Phenomenex ODS 3V C18 (4.6mm × 250 mm i.d, with a particle size of 5μm) with the mobile composition of methanol: phosphate buffer pH 7.1 (70:30) delivered at a flow rate of 1ml/min with the detection wavelength of 254 nm. It shows good linearity response in the concentration range of 15-35 μg/mL and 6-14 μg/ml for PCT and MFA with the retention times of 3.0 min and 4.8 min, respectively. The quantities of PCT and MFA in pharmaceutical suspension were found to be 99.01% and 101.02%, respectively. The method was quantitatively evaluated according to ICH guidelines taking into consideration the required parameters, and the results obtained are within acceptable limits. So, the proposed method can be employed in the routine analysis and evaluation of MFA and PCT in both bulk and suspension dosage form.


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