scholarly journals A Validated RP-HPLC Method for Simultaneous Estimation of Ciprofloxacin and Flucionolone in Pharmaceutical Formulation

2018 ◽  
Vol 6 (03) ◽  
pp. 48-51
Author(s):  
D. Mamatha ◽  
G. Naveen ◽  
Devi Singh
Keyword(s):  
Theoretical Plate ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Assay Method ◽  
Plate Count ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters

A simple, accurate, precise and sensitive RP-HPLC assay method have been validated for the simultaneous estimation of ciprofloxacin and flucionolone in pharmaceutical formulation by RP-HPLC .ciprofloxacin and flucionolone is separated using Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column at a flow rate of 0.8 ml/ min. Here resolution was good, theoretical plate count and symmetry was appropriate .The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 1.The validation parameters, tested in accordance with the requirements of ICH guidelines, prove the suitability of this method. The method was successfully applied for determination of drug in tablets, wherein no interference from tablet excipients was observed, indicating the specificity of the developed method.The proposed method was found to be simple, precise, accurate, rapid, economic and reproducible for the estimation of ciprofloxacin and flucionolone in pharmaceutical formulation.

QBD BASED RP-HPLC METHOD FOR SCREENING AND ANALYSIS OF TELAPRAVIR AND 7 OTHER ANTIRETROVIRAL AGENTS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (02) ◽  
pp. 20-33
Author(s):  
N. S Kumar ◽  
◽  
R Kumaraswamy ◽  
S. Shantikumar ◽  
D. Paul
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Full Factorial

The present study describes the separation and simultaneous estimation of eight anti-retroviral drugs, namely, Telaprevir (TPV), Emtricitabine (ECB), Fosamprenavir (FANV), Tenofavir (TNF), Ritonavir (RNV), Raltegravir (RGV) and Oseltamivir (OSMV) and Zidovudine (ZDV) as an active pharmaceutical ingredient, by RP-HPLC method by applying the principles of Quality by Design (QbD). An application of DoE (Design of Experiments) full factorial design was used for initial screening and optimization. The final optimized method consists of separation being carried out on a Fortis C18 column (150 mm × 4.6 mm, 5μ particle size) using acetonitrile and 10 mm ammonium formate buffer (pH 3 adjusted with formic acid) using a gradient program. The quantitative evaluation was performed with a diode array detector at 251 nm and 230 nm with a flow rate of 1 mL min–1. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the International Conference on Harmonization (ICH) guidelines. The method is selective, precise, robust and accurate and can be used for routine analysis of pharmaceutical formulations in quality control and counterfeit screening.

scholarly journals APPLICATION OF VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF ARMODAFINIL IN BULK AND FORMULATION

2017 ◽  
pp. 158-161
Author(s):  
Devi Ramesh ◽  
Mohammad Habibuddin
Keyword(s):  
Retention Time ◽  
Mobile Phase ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Isocratic Mode

Objective: The objective of the present study is to develop and validate a simple, rapid, sensitive reverse phase HPLC method for the determination of Armodafinil present in bulk and its pharmaceutical formulations.Methods: The chromatographic separation was achieved by using Hypersil ODS C-18 (150 x 4.6 mm, 5µ) in an isocratic mode with mobile phase methanol: phosphate buffer 3.0 (60:40 %v/v) was used. The flow rate was 1 ml/min and effluent was monitored at 225 nm. The method was validated for validation parameters i.e. linearity, accuracy, precision and robustness according to ICH guidelines.Results: The retention time of Armodafinil was 4.2 min and the linearity range of the method was 500-20000ng/ml with regression (r2) coefficient 0.9998. The method was validated for precision, accuracy, robustness and which were found to be within the acceptable limits according to the ICH guidelines. Also, the method was successfully applied for the estimation of Armodafinil in the marketed formulation of Nuvigil and the recovery was found to be>98%.Conclusion: The developed method possess good selectivity, specificity, there is no interference found in the blank at a retention time of ARM and good correlation between the peak area and concentration of the drugs under prescribed conditions. Hence, the method can be applied for routine analysis of Armodafinil. 

scholarly journals Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form

2020 ◽  
Vol 1 (4) ◽  
pp. 95-100
Author(s):  
Sonalika Patro ◽  
S. Harshith Kumar ◽  
M. Barath kumar ◽  
E. Masthaniah ◽  
K. Sairam ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Precision Study ◽  
Tablet Dosage

A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of  1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.

scholarly journals Stability-indicating HPLC-DAD method for the determination of empagliflozin

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Shilpi Pathak ◽  
Pradeep Mishra
Keyword(s):  
Hplc Method ◽  
Coefficient Of Determination ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Forced Degradation Studies ◽  
Tablet Dosage

Abstract Background A stability-indicating RP-HPLC method was developed and validated for the estimation of empagliflozin drug and its tablet dosage form using a DAD detector. The mobile phase consisted of methanol/acetonitrile/0.1%OPA (75:20:5). The peak was observed at 2.54 min using 222.0 nm absorption maxima. Results Calibration curve plot was found within the range of 10–50 µg/mL. The coefficient of determination (R2) was found to be 0.9990. Forced degradation studies were performed for the empagliflozin in various conditions, and the results were calculated as %RSD values and were found to be within the limits. Conclusion The method was validated as per ICH guidelines with respect to all validation parameters.

scholarly journals Validated RP-HPLC Method for the Determination of Ivabradine Hydrochloride in Pharmaceutical Formulation

2017 ◽  
Vol 9 (05) ◽  
Author(s):  
MD. Muzaffar -ur- Rehman1 ◽  
G. Nagamallika
Keyword(s):  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug

A simple, rapid, precise, and accurate RP-HPLC method for the estimation of Ivabradine Hydrochloride an anti-anginal agent, both as a bulk drug and in pharmaceutical formulation was developed. The chromatographic separation was achieved on a Thermosil C18 150 × 4.5 mm, 5μm column by using a mobile phase containing a mixture of methanol and phosphate buffer pH 6.5 in the ratio of 65:35 % v/v at a flow rate of 1ml/min and at an ambient temperature. The detection was monitored at a wavelength of 265nm. A clear chromatographic peak was identified with the retention time of 4.36 min and tailing factor of 1.23. The developed method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method shows a good linear relationship with correlation co-efficient of more than 0.992 in the concentration range of 30μg-150μg. The method showed mean % Recovery of 100.4% and %RSD for repeatability and intermediate precision was less than 2%. The proposed method can be used successfully for the quantitative determination of Ivabradine HCL in pharmaceutical dosage forms.

Validated Chromatographic Methods for Simultaneous Estimation of Cinnarizine in Binary Mixture with Domperidone and Paracetamol in Tablets

2019 ◽  
Vol 15 (5) ◽  
pp. 429-438
Author(s):  
Marianne Alphonse Mahrouse ◽  
Asmaa Ahmed El-Zaher ◽  
Ahmed Mohammed Al-Ghani
Keyword(s):  
Quality Control ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatographic Methods ◽  
Treatment And Prevention ◽  
Rp Hplc ◽  
Linear Relationships ◽  
Ich Guidelines ◽  
Analytical Tools

Background:Cinnarizine, an antihistaminic drug, is commonly formulated in combination with domperidone and with paracetamol for treatment and prevention of motion sickness and migraine.Objective:The aim of this work was to develop new, simple, precise and selective chromatographic methods (RP-HPLC and TLC-densitometric methods) for the determination of these drugs. These methods can be used as analytical tools in the routine examination in quality control laboratories.Methods:The first method was RP-HPLC method, the separation was carried out on an Inertsil® ODS- 3V C18 column (250 mm × 4.6 mm, 5 µm) using a mobile phase composed of methanol: acetonitrile (45: 55, v/v) at a flow rate of 1 ml/min. The detection was carried out at 220 nm. The second method was a TLC-densitometric method where the studied components were separated using a developing system composed of toluene: ethyl acetate: methanol: triethylamine (5: 4.3: 0.7: 0.5, v/v/v/v) on TLC silica gel 60 F254 plates, followed by densitometric scanning at 270 nm.Results:In RP-HPLC method, the peaks were sharp and well separated, the retention times were 5.25, 3.48 and 2.78 min, for cinnarizine, domperidone and paracetamol, respectively. Linearity was obtained over the concentration ranges 1-22, 0.75-16.5 and 25-550 µg/ml, for cinnarizine, domperidone and paracetamol, respectively. In TLC-densitometric method, good separation of spots and linear relationships were achieved over the concentration ranges of 0.2-2, 0.15-1.5 and 5-50 µg/spot, for cinnarizine, domperidone and paracetamol, respectively. Method validation was conducted according to ICH guidelines in terms of linearity, accuracy, selectivity, precision and robustness.Conclusion:The developed methods were applied for the determination of the cited drugs in tablets containing binary drug mixtures. The methods are simple and precise and can be used for routine analysis of the labelled drugs in combined dosage forms in quality control laboratories.

scholarly journals A Validated RP-HPLC Method for Simultaneous Estimation of Atenolol and Indapamide in Pharmaceutical Formulations

2011 ◽  
Vol 8 (3) ◽  
pp. 1238-1245 ◽  
Author(s):  
G. Tulja Rani ◽  
D. Gowri Sankar ◽  
P. Kadgapathi ◽  
B. Satyanarayana
Keyword(s):  
Particle Size ◽  
Mobile Phase ◽  
Dosage Form ◽  
Orthophosphoric Acid ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of atenolol and indapamide from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, methanol and water (adjusted to pH 2.7 with 1% orthophosphoric acid) in the ratio of 80:20. The flow rate was 1 mL/min and effluent was detected at 230 nm. The retention time of atenolol and indapamide were 1.766 min and 3.407 min. respectively. Linearity was observed in the concentration range of 12.5-150 µg/mL for atenolol and 0.625-7.5 µg/mL for indapamide. Percent recoveries obtained for both the drugs were 99.74-100.06% and 98.65-99.98% respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of atenolol and indapamide from their combined dosage form.

scholarly journals Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Bulk and in Tablet Dosage Form by UV-Spectrophotometry and RP-HPLC

1970 ◽  
Vol 4 (1) ◽  
pp. 58-63 ◽  
Author(s):  
Anandakumar Karunakaran ◽  
Vetsa Subhash ◽  
Ramu Chinthala ◽  
Jayamaryapan Muthuvijayan
Keyword(s):  
Simultaneous Equation ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Hplc Separation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Rosuvastatin Calcium

Two methods are described for the simultaneous estimation of Rosuvastatin Calcium and Fenofibrate in binary mixture. The first method was based on UV Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 243nm (λmax of Rosuvastatin Calcium) and 287nm (λmax of Fenofibrate) in methanol; linearity was obtained in the range of 1-6 μg/ml and 4-28 μg/ml for Rosuvastatin Calcium and Fenofibrate, respectively. The second method was based on HPLC separation of two drugs in reverse phase mode using Luna C18 column. Linearity was obtained in the concentration of 1-7 μg/ml and 4-28 μg/ml for Rosuvastatin Calcium and Fenofibrate, respectively. Both these methods have been successively applied to pharmaceutical formulation and were validated according to ICH guidelines.   Key words: Rosuvastatin Calcium; Fenofibrate; UV Spectrophotometry; HPLC; Method validation DOI: http://dx.doi.org/10.3329/sjps.v4i1.8868 SJPS 2011; 4(1): 58-63

scholarly journals Simultaneous Determination of Piracetam and Citicoline in Combination Drug Products by Rp-Hplc Method

2021 ◽  
pp. 171-185
Author(s):  
Meka. Srinivasa Rao ◽  
K. Rambabu
Keyword(s):  
Hplc Method ◽  
Simultaneous Estimation ◽  
Combination Drug ◽  
Drug Products ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
System Suitability ◽  
Relative Standard

In this paper a simple, accurate and precise RP-HPLC method for the simultaneous. Estimation of piracetam and citicoline in synthetic mixtures has been developed and validated. Separation of drugs was carried out using buffer and Acetonitryle with proportion of 60:40 %v/v as mobile phase at 5 min. run time and 265nm. The Rt value for piracetam and citicoline was found to be 3.158 and 5.196 min respectively. The developed method has been validated for linearity, accuracy and precision, LOD, LOQ, and system suitability according to ICH guidelines. The low values of LOD and LOQ illustrate that the developed method was sensitive, accurate, and precise as it can detected and quantify with very low concentration. The low % RSD values below 2 indicate that the method is precise. The above validation studies revealed the method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of piracetam and citicoline in combined dose products.

scholarly journals RP-HPLC method for simultaneous determination of escitalopram oxalate and flupentixol HCl in tablet dosage form

2021 ◽  
Vol 14 (1) ◽  
pp. 169-174
Author(s):  
Wrushali A. Panchale ◽  
Shivrani W. Nimbokar ◽  
Bhushan R. Gudalwar ◽  
Ravindra L. Bakal ◽  
Jagdish V. Manwar
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Recovery Study ◽  
Tablet Dosage

RP-HPLC method was developed for simultaneous determination of escitalopram oxalate (ESC) and flupentixol HCl (FLU) in tablet dosage form. Mobile phase consisting of mixture of acetonitrile and potassium phosphate buffer (pH 7.0 with 0.1% triethylamine) in the ratio 60: 40 at flow rate of 1ml/min using C18 Grace (250mmX 4.6mm) column at 231 nm. The retention time of ESC with FLU was found to be 2.96 min and 6.98 min, respectively. The linearity range for ESC with FLU observed was 5-25 µg/ml and 10-50 µg/ml, respectively. Method was validated as per ICH guidelines. Validation parameters studied were linearity and range, recovery study, precision, LOD, LOQ and robustness. Statistical data obtained was found to satisfactorily.

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