scholarly journals Validated HPLC Method for Assay and Content Uniformity Testing of Roflumilast in Blend and Tablets

2020 ◽  
Vol 32 (6) ◽  
pp. 1279-1285 ◽  
Author(s):  
N. Nukendra Prasad ◽  
R. Venkata Nadh ◽  
N. Srinivasu
Keyword(s):  
Enzyme Inhibitor ◽  
Hplc Method ◽  
Chronic Obstructive ◽  
Content Uniformity ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Obstructive Pulmonary Disease ◽  
Short Run ◽  
Content Uniformity Testing ◽  
Run Time

Roflumilast is a selective enzyme inhibitor of phosphodiesterase-4. This drug is recommended for treatment of patients suffering from chronic-obstructive-pulmonary-disease with chronic-bronchitis. Roflumilast is not official in pharmacopoeia and the reported methods are having high chromatographic run times. A short run time HPLC method was developed for assay and content uniformity testing to determine the roflumilast in blend and tablets. The mobile phase consists of 10 mM sodium dihydrogen phosphate monohydrate buffer and acetonitrile in the ratio of 45:55 v/v. The HPLC method was developed using accucore-C18 150 × 4.6 mm, 4 μm column with a flow rate of 1.0 mL min-1, 215 nm wavelength and 10 μL injection volume with run time of 5 min. The method linearity was proved between 5.02-40.17 μg mL-1 and obtained correlation-coefficient value is 1.0000. The mean recovery of roflumilast was 100.6%. The stability indicating nature was established and performed the validation by considering ICH Q2 (R1) recommendations.

Analytical methods for estimation of Budesonide in bulk and in Pharmaceutical dosage forms: A Review

2021 ◽  
pp. 2873-2877
Author(s):  
Anuja Kolsure ◽  
Kratika Daniel ◽  
Mahesh Bhat
Keyword(s):  
Analytical Methods ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Pharmaceutical Dosage Forms ◽  
Systemic Bioavailability ◽  
Term Management ◽  
Inflammatory Effect

Budesonide is a potent glucocorticoid with a high local anti-inflammatory effect and low systemic bioavailability. The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease. Several analytical methods including UV, HPLC, LC-MS techniques has been developed for Budesonide alone and in combination with others. Methods indicating HPLC bioanalytical method, stability indicating HPLC method, ion pairing chromatographic method and chemometrics assisted HPLC methods are also described for Budesonide. For qualitative and quantitative estimation of Budesonide these analytical methods can be used. The following study describes reported analytical methods of Budesonide.

scholarly journals Developement of Quantitative Analysis of Sparfloxacin by High Performance Liquid Chromatography

1970 ◽  
Vol 6 (1) ◽  
pp. 21-23
Author(s):  
Narun Nahar Rahman ◽  
Shahabuddin Ahmad
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Buffer Solution ◽  
Tablet Dosage ◽  
Liquid Chromatographic ◽  
Sodium Dihydrogen

An attempt has been made to develop a simple, sensitive and rapid high performance liquid chromatographic (HPLC) method of analysis for sparfloxacin using 35% acetonitrile in buffer solution as mobile phase. Buffer solution (40 mM of sodium dihydrogen phosphate in de-ionized water) was used as solvent to dissolve sparfloxacin and 0.05mg/ml stock solution was prepared. Sparfloxacin solution was scanned with UV-spectrophotometer and the absorption maximum (λmax) was found at 292 rim. This method was successfully applied to four tablet dosage forms of sparfloxacin encoded as ?, ?, ?, and ?, from four different companies and the result was found to be satisfactory and reproducible. Key words: Sparfloxacin, HPLC, analysis Dhaka Univ. J. Pharm. Sci. 6(1): 21-23, 2007 (June) The full text is of this article is available at the Dhaka Univ. J. Pharm. Sci. website

scholarly journals Development and Validation of a Simple RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Rosiglitazone in Pharmaceutical Dosage Forms

2013 ◽  
Vol 11 (2) ◽  
pp. 157-163
Author(s):  
Md Akteruzzaman ◽  
Asma Rahman ◽  
Md Zakir Sultan ◽  
Farhana Islam ◽  
Md Abdus Salam ◽  
...  
Keyword(s):  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

The objective of this study was to develop a simple, efficient, precise and accurate reversed phase HPLC (RP-HPLC) method for simultaneous determination of metformin in combination with rosiglitazone in newly formulated tablets. The combination of these drugs are commonly used and prescribed as anti-diabetic drugs in Bangladesh. The method has been developed by using the mobile phase comprising of sodium dihydrogen phosphate (NaH2PO4) buffer (pH 3.5) and acetonitrile (60:40, v/v) at a flow rate of 0.7 ml/min over C18 bonded silica column (ODS) (250 x 4.6 mm, 5 ?) at ambient temperature. The effluents were monitored at 230 nm and retention times were found to be 3.35 min and 11.95 min for metformin and rosiglitazone, respectively. Calibration curves were determined with a range from 0.03125 to 0.50 ?mole/ml of standards and the regression coefficients (r2) were found as 0.999 for metformin and 1.0 for rosiglitazone. The assay was validated for the accuracy, precision etc. according to ICH, USP and FDA guidelines. The proposed method can be useful in routine analysis for quantitative determination of metformin hydrochloride and rosiglitazone in pharmaceutical dosage forms. DOI: http://dx.doi.org/10.3329/dujps.v11i2.14574 Dhaka Univ. J. Pharm. Sci. 11(2): 157-163, 2012 (December)

Validated Stability-Indicating RP-HPLC Method for Simultaneous Determination of Clorsulon and Ivermectin Employing Plackett-Burman Experimental Design for Robustness Testing

2016 ◽  
Vol 99 (2) ◽  
pp. 571-578 ◽  
Author(s):  
Ahmed S Saad ◽  
Nahla S Ismail ◽  
Marwa Soliman ◽  
Hala E Zaazaa
Keyword(s):  
Experimental Design ◽  
Simultaneous Determination ◽  
Degradation Products ◽  
Hplc Method ◽  
Forced Degradation ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating

Abstract A sensitive and highly selective stability-indicating gradient HPLC method was developed and validated for simultaneous determination of clorsulon (CLO) and ivermectin (IVM) in the presence of their degradation products. The drugs were subjected to different stress conditions, including acid and alkaline hydrolysis, oxidative, thermal, and photolytic forced degradation. The robustness of the proposed method was assessed using the Plackett-Burman experimental design, the factors affecting system performance were defined, and nonsignificant intervals for the significant factors were determined. The separation was carried out on a ZORBAX SB phenyl analytical column (250 × 4.6 mm id, 5 μm particle size), with gradient elution utilizing 10 mM sodium dihydrogen phosphate and acetonitrile as mobile phase. UV detection was performed for CLO and IVM at 254 nm over a concentration range of 4–140 and 5–50 μg/mL, respectively, with mean percentage recoveries of 99.90 ± 1.30 and 98.59 ± 1.16%, respectively. The proposed method was successfully applied to a pharmaceutical dosage form containing the investigated drugs. The results were statistically compared with the official HPLC methods, and no significant differences were found.

scholarly journals Development of a Gradient HPLC Method for the Simultaneous Determination of Sotalol and Sorbate in Oral Liquid Preparations Using Solid Core Stationary Phase

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Ludmila Matysova ◽  
Oxana Zahalkova ◽  
Sylva Klovrzova ◽  
Zdenka Sklubalova ◽  
Petr Solich ◽  
...  
Keyword(s):  
Gradient Elution ◽  
Hplc Method ◽  
Potassium Sorbate ◽  
Dihydrogen Phosphate ◽  
Solid Core ◽  
Sodium Dihydrogen Phosphate ◽  
Solution Ph ◽  
Oral Liquid ◽  
Other Substances ◽  
Gradient Hplc

A selective and sensitive gradient HPLC-UV method for quantification of sotalol hydrochloride and potassium sorbate in five types of oral liquid preparations was developed and fully validated. The separation of an active substance sotalol hydrochloride, potassium sorbate (antimicrobial agent), and other substances (for taste and smell correction, etc.) was performed using an Ascentis Express C18 (100 × 4.6 mm, particles 2.7 μm) solid core HPLC column. Linear gradient elution mode with a flow rate of 1.3 mL min−1was used, and the injection volume was 5 µL. The UV/Vis absorbance detector was set to a wavelength of 237 nm, and the column oven was conditioned at 25°C. A sodium dihydrogen phosphate dihydrate solution (pH 2.5; 17.7 mM) was used as the mobile phase buffer. The total analysis time was 4.5 min (+2.5 min for reequilibration). The method was successfully employed in a stability evaluation of the developed formulations, which are now already being used in the therapy of arrhythmias in pediatric patients; the method is also suitable for general quality control, that is, not only just for extemporaneous preparations containing the mentioned substances.

Optimization and Validation of an HPLC-Photodiode Array Detector Method for Determination of Organic Acids in Vinegar

2015 ◽  
Vol 98 (2) ◽  
pp. 422-430 ◽  
Author(s):  
Yingying Zong ◽  
Jia Lin ◽  
Hua Xu ◽  
Zhihui Jia ◽  
Xiupei Yang ◽  
...  
Keyword(s):  
Organic Acids ◽  
Correlation Coefficients ◽  
Standard Addition ◽  
Hplc Method ◽  
Array Detector ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Photodiode Array Detection ◽  
Photodiode Array

Abstract A novel isocratic RP–HPLC method with UV photodiode array detection for the determination of seven organic acids in vinegar samples was developed and optimized. Samples were analyzed on a C18 (150 × 4.6 mm id, 5 μm) analytical column. Methanol–0.010 M sodium dihydrogen phosphate buffer adjusted with H3PO4 to pH 2.80 (2 + 98, v/v), was used as the mobile phase. The column oven temperature was optimized at 23.0°C, the flow rate was 0.80 mL/min, and the detection wavelength was 210 nm. Matrix-matched calibration curves were prepared for all analytes, and the correlation coefficients were greater than 0.99. LOD and LOQ ranged from 0.10 to 10.0 and 0.30 to 30.0 μg/mL, respectively. The results for interday and intraday precision and accuracy fell within the ranges specified. Vinegar samples were quantified by the standard addition method. The main advantages of this method are its selectivity, which is one of themain weaknesses of most methods when determining organic acids in complex matrixes, and its simplicity since little sample preparation is needed. Moreover,it is safe and inexpensive with low organic solvent usage.

scholarly journals Optimization and Establishment of a Validated Stability-Indicating HPLC Method for Study of the Stress Degradation Behavior of Metoprolol Succinate

2010 ◽  
Vol 93 (3) ◽  
pp. 911-916 ◽  
Author(s):  
Mitesh D Phale ◽  
Purnima D Hamrapurkar
Keyword(s):  
Degradation Products ◽  
Hplc Method ◽  
Stress Conditions ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Metoprolol Succinate ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Successful Separation ◽  
Stress Degradation

Abstract A stability-indicating HPLC method has been established for analysis of metoprolol succinate in the presence of products generated in a stress degradation study. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal decomposition. Extensive degradation was found to occur in an alkaline medium and under thermal stress. Minimum degradation was observed in an acidic medium and under photolytic and oxidative stress. Successful separation of the drug from its degradation products formed under stress conditions was achieved on a C18 column using sodium dihydrogen phosphate bufferacetonitrile (70 + 30) mobile phase. The flow rate was 1 mL/min, and the detection wavelength was 274 nm. The method was validated for linearity, range, precision, accuracy, LOQ, and LOD. Because the method effectively separates the drugs from their degradation products, it can be used as a stability-indicating method.

scholarly journals Optimization and Validation of an RP-HPLC Method for Direct Determination of Metformin Hydrochloride in Human Urine and in a Dosage Form

2010 ◽  
Vol 93 (6) ◽  
pp. 1821-1828 ◽  
Author(s):  
Alaa El-Gindy ◽  
Mohammed Wafaa Nassar ◽  
Nasr Mohammed El-Abasawy ◽  
Khalid Abdel-Salam Attia ◽  
Maisra Al-Shabrawi
Keyword(s):  
Human Urine ◽  
Direct Determination ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Linear Calibration ◽  
Rp Hplc ◽  
Acid Sodium Salt

Abstract A simple, selective, sensitive, accurate, and precise method was developed for determination of metformin hydrochloride (MF) in human urine using RP-HPLC. The method depends upon using an octylsilyl (C8) 5 m particle size column at ambient temperature with mobile phase consisting of 33 mM sodium dihydrogen phosphate containing 6.38 mM hexanesulfonic acid sodium salt and adjusted to apparent pH 3.0 with phosphoric acidacetonitrile (93 7, v/v) at a flow rate of 1.5 mL/min. Quantitation was achieved with UV detection at 231 nm based on peak area with a linear calibration curve over the concentration range of 0.0150 g/mL. The proposed method was applied to the determination of the urinary excretion pattern of MF (the cumulative amounts excreted were calculated without pretreatment of the urine sample) and for determination of the dissolution pattern of MF tablets. The proposed method was completely validated according to the U.S. Food and Drug Administration guidelines.

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