scholarly journals Evaluation and authentication for metformin HCL, Glimepride, atorvastatine by using bulk HPLC pharmaceutical dosage form

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 740-744
Author(s):  
Vennkata Ramana Pindi B ◽  
Sravani G ◽  
Ardhanaari M ◽  
Karthigai Priya M

Reverse phase chromatographic techniques are used for analyzing drugs. It is advanced analytical instrumentation method used for analysis of drugs. A novel accurate, precise, simple, & selective RP- HPLC technique is established and authorized for stability representing RP – HPLC technique for simultaneous assessment of Metformin HCL, Glimepiride & Atorvastatin in bulk & pharmaceutical dosage form by RP– HPLC technique. The technique on Luna C 18, 250mm × 4.6 mm, 15 µm. Column with a mobile phase comprising of buffer and acetonitrile in ratio of (85:15 v/v) and 1.0ml/ minflow rate. The detection is 258 nm. The retention time for metformin HCL, Atorvastatin & Glimepiride are discovered to be 3.266, 5.237 and 8.457 correspondingly. The technique authorized accordingly to ICH rules for precision, specificity, LOQ, LOD, accuracy, robustness, & linearity. The technique demonstrates best recovery &reproducibility with % RSD lower than 2. The suggested technique is discovered to be precise, simple, accurate, specific, &linear. The results are within the acceptance limits of lower than 2% signified that suggested technique has best reproducibility. The toughness of developed technique is validated by altering mobile phase composition, flow rate, and changing wavelength. The % RSD was found within the limits i.e., should not be more than 2.0.

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (12) ◽  
pp. 32-36
Author(s):  
T. Vishalakhi ◽  
◽  
S. K Kumar ◽  
K Sujana ◽  
P Rani

A simple validated RP HPLC method for the estimation of rizatriptan benzoate in pharmaceutical dosage form and bulk was developed for routine analysis. This method was developed by selecting Agilent TC C18 (250 x 4.6 mm, 5 μ) column as stationary phase and acrylonibrile:water (45:55), pH adjusted to 3, as mobile phase. Flow rate of mobile phase was maintained at 4: 1 mL/min at ambient temperature throughout the experiment. Quantification was achieved with ultraviolet (DAD) detection at 220 nm. The retention time obtained for rizatriptan was 2.8 min. The detector response was linear in the concentration range of 2-25μg/mL. This method was validated and shown to be specific, sensitive, precise, linear, accurate, rugged and robust. Hence, this method can be applied for routine quality control of rizatriptan benzoate in dosage forms as well as in bulk drug.


Author(s):  
Atul S. Sayare ◽  
Priti B. Undre ◽  
Prashant D. Ghode ◽  
Sujata V. Singh ◽  
Shweta P. Ghode

A simple, specific, precise, and accurate RP-HPLC method has been developed and validated for the estimation of Clomiphene citrate in bulk and pharmaceutical dosage form using C18 column Shimadzu (250mm × 4.5mm × 5μm) with a mobile phase consisting of 900mL of HPLC grade methanol and 100mL of HPLC grade acetonitrile. The mobile phase was sonicated for 10 min and filtered through a 0.45μm membrane filter at a flow rate of 1.0mL/min. The detection was carried out at 295nm and retention time of Clomiphene citrate was found to be 3.44 min. Linearity was observed in the concentration range of 10–50μg/mL (coefficient of determination R2=0.999) with regression equation y =20321x + 60021. The method was validated as per ICH guidlines.


2011 ◽  
Vol 8 (1) ◽  
pp. 453-456 ◽  
Author(s):  
K. Srinivasu ◽  
J. Venkateswara Rao ◽  
N. Appala Raju ◽  
K. Mukkanti

A validated RP HPLC method for the estimation of atazanavir in capsule dosage form on YMC ODS 150 × 4.6 mm, 5 μ column using mobile phase composition of ammonium dihydrogen phosphate buffer (pH 2.5) with acetonitrile (55:45 v/v). Flow rate was maintained at 1.5 mL/min with 288 nm UV detection. The retention time obtained for atazanavir was at 4.7 min. The detector response was linear in the concentration range of 30 - 600 μg/mL. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Hence, this method can be applied for routine quality control of atazanavir in capsule dosage forms as well as in bulk drug.


INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (01) ◽  
pp. 35-40
Author(s):  
Rajesh Sharma ◽  
◽  
Mukesh C. Sharma ◽  
Gaurav Vijaywargiya

Chromatographic separation of paracetamol, aceclofenac and tramadol hydrochloride was performed on a Chromatopak C-18 column (25 cm x 4.6mm i.d. x 5µm) as stationary phase with a mobile phase composed of phosphate buffer pH 7.0: acetonitrile (65:35 V/V), pH 7.0 (adjusted with triethylamine) at flow rate of 1mL/min. Detection was carried out at 265 nm. The retention times of paracetamol, aceclofenac and Tramadol hydrochloride were found to be 2.7, 4.5 and 6.0 min, respectively. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The method was found to be accurate, precise, specific, robust, and linear for the determination of paracetamol, aceclofenac and tramadol hydrochloride in pharmaceutical dosage form.


Author(s):  
V Pavan Kumar ◽  
T Supriya ◽  
B Sivagami ◽  
R Sireesha ◽  
R Charan Kumar ◽  
...  

A simple, accurate, rapid and precise method was developed for the simultaneous estimation of Ibuprofen and Diphenhydramine in Pharmaceutical dosage form. Chromatogram was run through Inertsil ODS (250x4.6mm) 5µ. Mobile phase used was Acetonitrile and Phosphate buffer (45:55) at a flow rate of 1.0 ml/min and detection wavelength was found to be 260 nm. The retention time was found to be 2.32 min and 2.93 min for Ibuprofen and Diphenhydramine respectively. The accuracy and reliability of the method was assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2), accuracy (98-102%), specificity, LOD, LOQ values in accordance with ICH guidelines. The developed method is applicable for routine quality control analysis of selected combined dosage forms.


2019 ◽  
Vol 9 (1) ◽  
pp. 170-174
Author(s):  
Anjali Bakshi ◽  
K Monika ◽  
Shweta Bhutada ◽  
M. Bhagvan Raju

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Gabapentin & Methylcobalamin from bulk and formulation. Chromatographic separation was achieved Isocratically on an Inertsil C18 column (150x4.6, 5µ particle size) using a mobile phase Buffer: Acetonitrile in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, effluents were detected at 264 nm and 10µl of sample was injected. Retention time of Gabapentin & Methylcobalamin was found to be 2.7 and 4.13 min respectively. Linearity of the method was in the concentration range of 25-150 µg for Gabapentin & 0.125-0.750 µg for Methylcobalamin. Percent recoveries obtained for both the drugs were 100.00%. The percentage RSD for precision of the method was found to be less than 2%. The method was validated according to the ICH guidelines. The method developed was successfully applied for the analysis of simultaneous estimation of Gabapentin & Methylcobalamin tablets and was fairly good in comparison with other methods. Keywords: Gabapentin, Methylcobalamin, HPLC.


2009 ◽  
Vol 6 (s1) ◽  
pp. S59-S64 ◽  
Author(s):  
Prafulla Kumar Sahu ◽  
M. Mathrusri Annapurna

RP-HPLC analytical method for the estimation of nabumetone in pharmaceutical dosage forms was developed and validated. A Hypersil ODS C18, 4.6 mm x 250 mm, 5 μm column from Supelco (India), with mobile phase comprised of acetonitrile: triple distilled water (50:50) with a total run time of 18 min was used and the wavelength of the detector was set at 230 nm. Stavudin is used as internal standard. The retention times were 14.167 min and 1.967 min for nabumetone and stavudin (IS) respectively. The extraction recovery of nabumetone from pharmaceutical dosage form (tablets) was >101% and the calibration curve was linear (r2= 0.995) over nabumetone concentrations ranging from 1 to 200 µg/mL. The method had an accuracy of >99% and LOD and LOQ of 0.17482 µg/mL and 0.5827 µg/mL respectively. The method reported is simple, reliable, precise and accurate and has the capability of being used for determination of nabumetone in bulk and pharmaceutical dosage forms.


INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (01) ◽  
pp. 38-46
Author(s):  
Z. G Khan ◽  
◽  
S. J. Surana ◽  
A. A. Shirkhedkar

Tadalafil is a selective phosphodiesterase Type 5 enzyme inhibitor. Simple and sensitive High Performance Thin - Layer Chromatography (HPTLC) and Reversed - Phase High - Performance Liquid Chromatography (RP-HPLC) methods have been developed for estimation of tadalafil in pharmaceutical dosage form. Separation of tadalafil was achieved on HPTLC aluminum sheets of silica gel 60 F254 with mixture of toluene: methanol (7.2: 2.8 V/V) as the mobile phase. tadalafil obeyed linearity in the concentration range of 300 - 800 ng/band with correlation coefficient (r2) 0.9994. Detection was performed densitometricaly at 284 nm with Rf 0.50 ± 0.02. RP-HPLC separation was achieved using Qualisil C18 column on mixture of methanol: water (75: 25 % V/V) as the mobile phase. Linearity was plotted in range of 2 – 12 μg/mL and (r2) value as 0.9998. The retention time was found to be 4.82 ± 0.02 min. The developed HPTLC and RP-HPLC methods have been successfully applied for the determination of tadalafil in bulk and pharmaceutical formulation. Both these methods were statistically compared.


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