scholarly journals Analysis on Bulk Pharmaceutical Formulation, Validation and Estimation Using Levetiracetam Methods

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 292-295
Author(s):  
Smitha M ◽  
Kal Satyavathi Devi ◽  
Virendra Kumar ◽  
Jaffar Hussain

A new sensitive, specific, direct, exact and correct RP-HPLC technique is established and authenticated to estimate Levetiracetam in Majority and Pharmaceutical Tablet Formulations. An isocratic, turned around period HPLC system might have been created should differentiate the pill starting with the corruption products, Phenomenex Gemini 5µ C18 (2) 100A (250 x 4.60mm, 5 µ) section. Hamilton syringe (705 NR, 50 µL) might have been utilized to injecting example Furthermore standard result. The versatile stage comprises about mixture of Methanol: Acetonitrile in the proportion (90:10 v/v) toward A stream rate about 1.0 ml /min. UV identification might have been performed toward 210 nm. The linearity might have been made for Levetiracetam in the extent from claiming 5- 30µg/ml for relationship coefficient about 0.9997. LOD Also LOQ were found will make 0.076µg/ml Furthermore 0.23µg/ml individually. Maintenance duration of the time of Levetiracetam were found with make 2.281min and 2.274min. % recuperation might have been discovered on be 99.78-100.45 What's more %RSD might have been found for over ±2. Those system needs been approved as stated by ICH rules to linearity, precision, accuracy, robustness, ruggedness, LOD furthermore LOQ. Those produced approved system might have been effectively connected to dependable quantification about Levetiracetam to mass and pharmaceutical measurement type.

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
J. Saroja ◽  
Anantha Lakshmi P.V. ◽  
Y. Rammohan ◽  
D. Divya Reddy

Abstract Background We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. Individual quantification of DEH and DEC was reported. But simultaneous quantification of DEH and DEC was lacking. DEH and DEC were analysed on an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” with the mobile phase solvent run isocratically with 0.1M K2HPO4-acetonitrile (55:45, v/v) on a flow speed of 1.0 mL/min. Results The chromatographic run period for the DEC and DEH assay was 6.0 min with retention times of 2.134 and 2.865 min, respectively. The method was validated for accuracy (99.453 to 100.417% and 99.703 to 100.303% recovery values for DEH and DEC, respectively), precision (RSV value 0.135% for DEC and 0.171% for DEH), linearity (5–15 μg/mL for DEH and 20–60 μg/mL for DEC), selectivity (no hinderance from excipients) and specificity (no hinderance from degradants) recovery. Conclusion The developed stability-indicating liquid chromatography process was well applied to established tablet formulations.


2020 ◽  
Vol 11 (1) ◽  
pp. 781-789
Author(s):  
Sriram Valavala ◽  
Nareshvarma Seelam ◽  
Subbaiah Tondepu ◽  
Suresh Kandagatla

The present study aims to develop a simple, accurate and specific stability-indicating RP-HPLC technique for the analysis of metoclopramide in the presence of its stress degradation products and characterization of degradation compounds by LC-MS/MS analysis. As per ICH Q1A-R2 guidelines, the drug was exposed to acid hydrolytic stress condition. Three degradation products were formed for MCP in acid hydrolysis. The liquid chromatography was processed on a Luna C18-(2) 100A,250×4.6mm 5micron column using an isocratic mobile phase consisting of 0.1% formic acid in water-acetonitrile (20:80, v/v) by adjusting the mobile phase at 1 ml/min flow rate with wavelength detection at 273 nm. The developed procedure was applied to LC-MS/MS (liquid chromatography-tandem mass spectrometry) for the characterization of all the degradant components. Total new three degradation compounds were recognized and identified by LC-MS/MS. The developed RP-HPLC technique was validated as per the ICH Q2-R1 guidelines. Limit of detection and limit of quantification values of MCP were evaluated from the linearity graph and were found to be 5.23 µg/ml and 17.44 µg/ml. Accuracy study was established at 80.0, 100.0 and 120.0 µg/ml concentration levels and the findings were found in the range of 98.4% - 101.8%. The linearity of the technique was assessed over the drug concentration range of 50.0 µg/ml to 250.0 µg/ml and the regression equation, slope and correlation coefficient values were found to be y = 10618x + 1623.2, 10618 and 0.9996 respectively. The developed technique was uninterruptedly applied for the quantification of metoclopramide inactive pharmaceuticals.


2020 ◽  
Vol 12 (3) ◽  
pp. 155-165
Author(s):  
Pooja Eknathji Waware ◽  
Anuja Dattatriayji Jolhe ◽  
Swati Rajendra Lilhare ◽  
Prasad Prakash Jumade ◽  
Dharmendra Ramgopalji Mundhada

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