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 Estimation of Domperidone and Pantoprazole in Solid Dosage Form by UV Spectrophotometry

2006 ◽  
Vol 3 (3) ◽  
pp. 142-145
Author(s):  
P. Ravi Kumar ◽  
P. Bhanu Prakash ◽  
M. Murali Krishna ◽  
M. Santha Yadav ◽  
C. Asha Deepthi
Keyword(s):  
Simultaneous Equation ◽  
Simultaneous Equations ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Q Value ◽  
Value Analysis ◽  
Spectrophotometric Methods ◽  
Solid Dosage ◽  
Tablet Dosage

Domperidone is an antiemetic and pantoprazole is an antiulcer drug. Simple, precise, rapid and selective simultaneous equation and Q- analysis UV spectrophotometric methods have been developed for the simultaneous determination of domperidone and pantoprazole from combined tablet dosage forms. The methods involve solving of simultaneous equations and Q-value analysis based on measurement absorptivity at 216, 287 and 290 nm respectively. Linearity lies between 1-15 mcg/mL for domperidone and 0-50 mcg/mL for pantoprazole.

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 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 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.

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 A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PYRANTEL PAMOATE AND PRAZIQUANTEL IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
pp. 62-67 ◽  
Author(s):  
Rajesh R. ◽  
JITHU JERIN JAMES
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Correlation Coefficients ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Pyrantel Pamoate ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage

Objective: To develop a simple, accurate and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method and subsequently validate for the simultaneous estimation of praziquantel (PZQ) and pyrantel pamoate (PP) in the pharmaceutical dosage form. Methods: The chromatographic separation was achieved on Phenomenex Luna C18 column (250 mm × 4.6 mm, 5 μm) as stationary phase maintained at an ambient temperature with a mobile phase comprising of water: acetonitrile (20: 80) at a flow rate of 1.0 ml/min and UV detection at 220 nm. Results: The retention time of PZQ and PP was found to be 3.897 min and 1.697 min respectively. The method was validated in terms of specificity, accuracy, precision, linearity and robustness as per ICH guidelines. Linearity was obtained in the concentration range of 20–60 μg/ml for both PZQ and PP with correlation coefficients of 0.987 and 0.998 respectively. The accuracy of the method was determined using a recovery test and found as 98.44 % to 100.35 %. All parameters are found to be within the acceptable limit. Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise for the simultaneous estimation of PZQ and PP in bulk and tablet dosage form.

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.

Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

2021 ◽  
pp. 4767-4772
Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Solution Stability ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR RILPIVIRINE HYDROCHLORIDE IN BULK AND USE IN ANALYSIS OF PREPARED NANOSUSPENSION

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (04) ◽  
pp. 42-46
Author(s):  
Madhuri Manchala ◽  
◽  
Vijaya Sri Kanagala ◽  
Ganapath Vinay Jain
Keyword(s):  
Homogenization Method ◽  
Hplc Method ◽  
Array Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Photodiode Array Detector ◽  
Photodiode Array ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise, accurate and robust RP-HPLC-PDA method was developed and validated for the determination of rilpivirine hydrochloride in tablet dosage forms. Reverse-phase chromatography was performed on a BDS hypersil (250 mm × 4.6 mm, 6 μm) column of Waters HPLC with Empower software and with a photodiode array detector. Methanol: acetonitrile: water 80:13.5:6.5 (v/v) was used as the mobile phase at a flow rate of 1 mL min-1 with PDA detection at 306 nm. Rilpivirine hydrochloride nanosuspension was prepared by using an ultrasonic homogenization method. Linearity was observed in the concentration range of 0.1–10 μg mL-1 with regression equation y = 508856X+46908 (R2 = 0.9998). The method was validated as per ICH guidelines. The RSD for intra-day (1.31- 0.67) and inter-day (1.69-1.59) precision was found to be less than 2%. The developed method is simple, precise and robust for the determination of rilpivirine hydrochloride and is successfully applied for the nanosuspension.

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.

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