Background: A Simple, sensitive, and specific stability indicating reverse phase HPLC method was developed for simultaneous estimation of Lamivudine and Dolutegravir in bulk and tablet dosage form. Effective separation was achieved by injecting10 μL of the standard solution into Xbridge Phenyl (250 × 4.6 mm, 5 μ,100 A 0 ) column, using a mobile phase composition of methanol: buffer (0.1% v/v trifluoroacetic acid in water) (85:15 v/v) and isocratic elution programming have been done at a flow rate of 0.8 mL/min. The eluted analytes detected at 258 nm wavelength. The stress conditions such as acid, base, oxidative, thermal, and photo stability were applied as per ICH guidelines to determine the stability of the drugs in different environmental conditions. Results: The retention times of Lamivudine and Dolutegravir were found to be 3.4 and 5.0 min respectively. The developed method was linear in the concentration range of 5-15 μg/mL and 30-90 μg/mL for Dolutegravir and Lamivudine respectively. Detection and quantification limits were observed at 3.6 and 11 μg/mL for Lamivudine and 0.50 and 1.5 μg/mL for Dolutegravir. Method validation parameters were within the acceptance criteria of ICH guidelines, and the degradation products were well resolved from Dolutegravir and Lamivudine peaks, which indicate the stability of the method. Conclusion: The developed RP-HPLC method was highly precise, specific, sensitive, and stability indicating. Hence, the method has the ability to use in quality control department for regular analysis for the estimation of Lamivudine and Dolutegravir.
Objective: The most important objective of the present research work is to develop simple, specific, rapid, accurate, and sensitive reverse-phase high-performance liquid chromatography method and validated for the qualitative and quantitative determination of valsartan in its active pharmaceutical ingredient and tablet dosage form according to ICH guidelines.Proposed Method: An isocratic separation was done using Phenomenex C18 column possess 75×4.6 mm, 2.6 μ,100 A0 dimensions with mobile phase composition of water:acetonitrile (30:70% v/v) by maintaining 1 ml/minute flow rate and response detected at a wavelength of 247 nm.Results: The retention time of valsartan was found to be 2.71 minutes, limit of detection and limit of quantification were observed at 1.24 μg/ml and 3.6 μg/ml concentration, respectively, and a calibration curve was linear in the concentration range of 5-50 μg/ml with coefficient of correlation 0.99. The percentage recovery (accuracy) was in the range of 98.9-102%, and the % relative standard deviation was observed to be <2%.Conclusion: The proposed method was validated for accuracy, precision, sensitivity, linearity, and robustness and successfully employed for the quantitative determination of valsartan in tablet dosage form in quality control department of pharmaceutical industry.
Background
An easy, defined, rapid, and accurate reverse phase high-performance liquid chromatography method was developed and subsequently validated for the concurrent estimation of lamivudine, efavirenz, and tenofovir disoproxil fumarate in their pure blend and combined tablet formulation. An efficient and appropriate separation of the three analytes was attained with Zorbax eclipse XDB-Phenyl column, with a mobile phase of methanol: buffer (0.1% v/v formic acid in water) (73:27 v/v) at a flow rate of 1mL/min and isocratic elution by using 260nm as detection wavelength. Equal ratio of acetonitrile and water was used as diluent.
Results
The retention times of lamivudine, tenofovir disoproxil fumarate, and efavirenz were found at 2.6, 4.4, and 5.9 min respectively. The linear response for lamivudine, tenofovir disoproxil fumarate, and efavirenz was in the range of 15.0–45.0μg/mL, 15.0–45.0μg/mL, and 20.0–60.0 μg/mL respectively. The method validation was done in accordance to ICH guidelines and all validation parameters in compliance with ICH standards. The degradants produced by stress testing were well resolved from the peaks of active analytes, which stipulates the stability-indicating property of the method.
Conclusion
The method has the ability to separate lamivudine, efavirenz, and tenofovir disoproxil fumarate concurrently in blended powder and their combined tablet. All degradants produced by application of stress conditions were separated with high resolution and determined with good sensitivity that ensures the stability-indicating property of the method. Thus, the projected method has high probability to adopt in the pharmaceutical industrial sector.
Favipiravir is a potential repurpose moiety to treat COVID-19 by depletion of virus load in infectious patients. To analyze and separate Favipiravir with remarkable effi ciency, X-Bridge C8 column (150 x 4.6 mm, 5 μ) and a solvent phase of 0.1% TEA and acetonitrile (40:60 v/v) with 1-mL/min fl ow rate were used. The eluted favipiravir and possible degradants were detected at 225 nm. Further, the process was validated by using ICH (Q2R1) guidelines to ensure the method’s suitability in the pharmaceutical sector. The RT of Favipiravir was observed at 3.7 min with good linearity of 2 to 30 μg/mL. %RSD of both system and method precision was assessed in the series of 0.32 to 0.98. The mean percentage recovery of Favipiravir was in the range of 99.0–100.4%. The limit of detection (LoD) and limit of quantifi cation (LoQ) were assessed to be 0.024 and 0.084 μg/mL for favipiravir. The outcomes confi rmed that the projected approach was economical, insightful, simple and precise with better sensitivity. Investigation of Favipiravir in the incidence of a variety of stressed or forced degradation environments ensures stability indicating quality of the developed approach
The synthesis and biological evaluation of novel pyrazole based heterocycles attached to sugar moiety lead to creating a new molecular frame work. Nine new compounds were synthesized by reacting ethyl 2-((2-(4-methoxyphenyl)-5-methyloxazol-4-yl) methyl)-3-oxobutanoate derivatives (9a-9c) with different alkyl hydrazines to give various substituted 4-((2-(4-methoxyphenyl)-5-methyloxazol-4-yl) methyl)-5-methyl-1H-pyrazol-3-ol derivatives (10 a-10i) which in turn were reacted with bromoglucose (3)to yield R1, R2 substituted 2-(4-((2-(4-alkoxyphenyl)-5-methyloxazol-4-yl)methyl)-1-alkyl-5-methyl-1H-pyrazol-3-yloxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (12a-12i). The chemical structures of the synthesized compounds were characterized by means of IR, Mass and NMR spectroscopy. The compounds were screened for anti-diabetic activity by urinary glucose excretion method (UGE). Among the compounds tested, 12f, 12h and12i have exhibited moderate anti-diabetic activity as that of standard drug, remogliflozin. These compounds can be further exploited to get the potent lead compound.
Sofosbuvir is a regularly used antiviral medication that was approved for clinical usage in hepatitis C patients. Sofosbuvir belongs to the nucleotide analog drug class, and it operates by inhibiting hepatitis C NS5B protein. This study focuses on the many analytical methods for detecting and quantifying Sofosbuvir in pharmaceutical formulations, biological samples, and fixed dosage combinations. Chromatographic techniques, electro-analytical methods, chemometric procedures, and optical approaches are just a few of the approaches mentioned in the literature. The most often used methods for the analysis of Sofosbuvir are HPLC-based methods with UV/Vis spectrophotometric, fluorescence, and mass spectrometric detection. This article could be extremely useful in the creation of upcoming Sofosbuvir analytical approaches or investigations.
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