scholarly journals Development and Validation of an RP-HPLC Method for CB13 Evaluation in Several PLGA Nanoparticle Systems

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
J. Álvarez-Fuentes ◽  
L. Martín-Banderas ◽  
I. Muñoz-Rubio ◽  
M. A. Holgado ◽  
M. Fernández-Arévalo

A simple, fast, and reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for determining of a cannabinoid derivate, which displays potent antihyperalgesic activity, 1-naphthalenyl[4-(pentyloxy)-1-naphthalenyl]methanone (CB13) into PLGA nanoparticles. Separation was achieved in a C18 column using a mobile phase consisting of two solvents: solvent A, consisting of acetonitrile : water : acetic acid (75 : 23.7 : 1.3 v/v), and solvent B, consisting of acetonitrile. An isocratic method (70 : 30 v/v), with a flow rate of 1.000 mL/min, and a diode array detector were used. The developed method was precise, accurate, and linear over the concentration range of analysis with a limit of detection and a limit of quantification of 0.5 and 1.25 μg/mL, respectively. The developed method was applied to the analysis of CB13 in nanoparticles samples obtained by three different procedures (SEV, FF, and NPP) in terms of encapsulation efficiency and drug release. Nanoparticles size and size distribution were also evaluated founding that NPP method presented the most lowest particle sizes with narrow-size distribution (≈320 nm) and slightly negative zeta potential (≈−25 mV) which presumes a suitable procedure for the synthesis of PLGA-CB13 nanoparticles for oral administration.

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (05) ◽  
pp. 48-52
Author(s):  
A Lodhi ◽  
◽  
A Jain ◽  
B. Biswal

A validated high performance liquid chromatographic method was developed for the determination of chromium picolinate in pharmaceutical dosage forms. The analysis was performed at room temperature using a reversed-phase ODS, 5µm (250×4.6) mm column. The mobile phase consisted of acetonitrile: buffer (60:40 V/V) at a flow rate of 0.5 mL/min. The PDA-detector was set at 264 nm. The developed method showed a good linear relationship in the concentration range from 1.5 – 12.5 µg/mL with a correlation coefficient from 0.999. The limit of detection and limit of quantification were 0.0540513 and 0.1637919 µg/mL respectively.


1970 ◽  
Vol 3 (1) ◽  
pp. 49-53 ◽  
Author(s):  
Gaurav Patel ◽  
Sanjay Patel ◽  
Dhamesh Prajapiti ◽  
Rajendra Mehta

A reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in combine dosage form. Amlodipine Besylate (AML) is a long acting calcium channel blocker and in the treatment of CVS disorder. Hydrochlorothiazide (HCT) is a diuretic and antihypertensive. The mobile phase used was a combination of Water: Methanol (70:30). The detection of the combined dosage form was carried out at 245nm and a flow rate employd was 0.5ml/min. The retention time for Amlodipine Besylate and Hydrochlorothiazide was found to be 6.95 and 2.65 min respectively. Linearity was obtained in the concentration range of 6 to 18μg/ml of Amlodipine Besylate and 6 to 18μg/ml of Hydrochlorothiazide with a correlation coefficient of 0.997 and 0.9974. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (5 μm size, 250mm, 4.6mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method is precise, selective and rapid for simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in routine analysis. Key Words: Simultaneous Estimation; Amlodipine Besylate; Hydrochlorothiazide; HPLC. DOI: 10.3329/sjps.v3i1.6798S. J. Pharm. Sci. 3(1): 49-53


Author(s):  
Sunkara Namratha ◽  
Vijayalakshmi A

Objective: Reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed for the assessment of lopinavir in the dosage form of tablet.Methods: Chromatogram was run through using Kromosil C18 4.5×150 mm using a mobile phase methanol: water of ratio 65:35% v/v with a rate of flow of 0.8 ml/min, measured by UV spectrometric detection at 265 nm. The method developed was validated in terms of precision, accuracy, linearity, and robustness parameters.Results: Retention time of lopinavir established at 2.482 min and percentage R.S.D of lopinavir found to be 1.0% and 0.5%, respectively. The method shows that good linearity range of 30–150 μg correlation coefficient of lopinavir was 0.997. The limit of detection was 2.97 and limit of quantification was 9.92, respectively. The percent purity of lopinavir was 99.87%.Conclusion: The suggested method (Rp-HPLC) for concurrent assay lopinavir was validated, which is appropriate method for the analysis oflopinavir quantitatively in tablet dosage forms and bulk.


2012 ◽  
Vol 10 (2) ◽  
pp. 67-70
Author(s):  
Abdullah Al Masud ◽  
Mohammad Saydur Rahman ◽  
Towfika Islam ◽  
Saki Sultana ◽  
Moynul Hasan ◽  
...  

A simple, reproducible and efficient reversed phase high performance liquid chromatographic (RPHPLC) method has been developed for the estimation of a recently approved anti allergic drug, amlexanox in oral paste dosage form. The separations were carried out on a Zorbax Eclipse XBD, C18 column (150 x 4.6 mm; 5?m) at a flow rate of 1.50 ml/min. by using mobile phase comprising of mixed buffer (pH adjusted to 6.50) and methanol (50:50 v/v). The injection volume was 10 ?l and the peaks were detected at 244 nm. The linear dynamic range found to be in the concentration range of 15-35 ?g/ml and coefficient of correlation was found to be 0.999. The %RSD value was below 2.0 for intra-day and inter-day precision which indicated that the method was highly precise. The LOD (Limit of detection) and LOQ (Limit of quantitation) were found to be 3.8 ng/ml and 12.5 ng/ml, respectively which revealed that the method was highly sensitive. The percentage recovery of amlexanox ranged from 99.31 to 99.75%, indicating the accuracy of the method and absence of interference from the excipients present in the formulation. The proposed method was simple, fast, accurate and reproducible and hence can be applied for routine quality control operations of amlexanox in oral paste dosage form. Key words: Amlexanox, Anti allergic, RP-HPLC, LOD, LOQ. DOI: http://dx.doi.org/10.3329/dujps.v10i2.11782 Dhaka Univ. J. Pharm. Sci. 10(2): 67-70, 2011 (December)


Author(s):  
K Tirumala ◽  
CH.V.S Gautam ◽  
J Gangadhar ◽  
M Jayajeevitha ◽  
Vanitha Prakash K

Reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of pitavastatin in tablet dosage form. A Phenomenex Luna C18, 150×4.6 mm i.d, 5 µm particle size with mobile phase consisting of buffer 0.01M potassium dihydrogen ortho phosphate pH (3.75) adjusted with dilute orthophosphoric and acetonitrile in the ratio of 20:80 v/v was used. The flow rate was 1.2 mL/min and eluents were monitored at 248 nm. The retention time was 4.1min. The detector response was linear in the concentration of 25-150 µg/mL, with the regression coefficient of 0.9998. Quantification was done by calculating area of the peak and the limit of detection and limit of quantification were 1.9 µg/mL and 5.7 µg/mL respectively. The percentage assay of pitavastatin was 101.1%. The results of study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate which is useful for the routine determination of pitavastatin in bulk drug and in its pharmaceutical dosage forms.


2010 ◽  
Vol 2010 ◽  
pp. 1-5 ◽  
Author(s):  
Ayman Khdair ◽  
Mohammad K. Mohammad ◽  
Khaled Tawaha ◽  
Eman Al-Hamarsheh ◽  
Hatim S. AlKhatib ◽  
...  

A simple reversed phase high-performance liquid chromatographic (RP-HPLC) method coupled with a photodiode array detector (PAD) has been developed and validated for the analysis of hederacoside C, the marker of ivy plant, in Ivy-Thyme cough syrup. Separation of hederacoside C was achieved using a Phenomenex-Gemini C18 column isothermally at C. A mobile phase system constituted of solvent A (water: acetonitrile: orthophosphoric acid (85%), 860 : 140 : 2 v/v) and solvent B (acetonitrile: orthophosphoric acid (85%), 998 : 2 v/v) was used, at gradient conditions, at a flow rate of 1.5 mL/min. Analysis was performed using UV-detection (205 nm). The method was linear over the range (0.03–0.15) mg/mL of hederacoside C (). Repeatability and intermediate precision were acceptable (RSD %). Limits of detection (LOD) and quantitation (LOQ) were 0.011 and 0.032 mg/mL, respectively. Percentage recovery was found to lie between 99.69% and 100.90% (RSD %). The method was also proved to be specific (peak-purity ).


2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
S. Sowjanya ◽  
Ch. Devadasu

A reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for simultaneous estimation of levamisole and albendazole in drug substance and in its combinational dosage form. The analysis was carried out usingInertsil ODSC18(4.6 x 150 mm, 5μm) column, and the separation was carried out using a mobile phase containing a buffer of pH 3.5 and acetonitrile (70:30 v/v) pumped at a flow rate of 1.0 mL/min with variable wavelength UV-detection at 224 nm. Both the drugs were well resolved in the stationary phase and the retention times were 2.350 min and 4.055 for levamisole and albendazole, respectively. The method was validated and shown to be linear in the concentration range of 15-45μg/ml and 40-120μg/ml for levamisole and albendazole, respectively. The limit of detection (LOD) and limit of quantification (LOQ) were determined based on standard deviation of the y-intercept and the slope of the calibration curve. LOD and LOQ values were 2.08μg/ml and 6.03μg/ml for levamisole and 3.15μg/ml and 10.40μg/ml for albendazole, respectively. The accuracy of the method was assessed by adding known amount of standard solution (75 %, 100 %, and 125% of the sample concentration) to the preanalyzed sample solution of 100% concentration. All the samples were prepared and analyzed in triplicate. The percentage mean recovery by standard addition experiments of levamisole and albendazole is 99.66% and 98.73%, respectively.


2011 ◽  
Vol 8 (4) ◽  
pp. 1958-1964 ◽  
Author(s):  
H. R. Prajapati ◽  
P. N. Raveshiya ◽  
J. M. Prajapati

A reversed phase high performance liquid chromatographic (RP–HPLC) method was developed and subsequently validated for the determination of atomoxetine hydrochloride in bulk and pharmaceutical formulation. The separation was done by a PerkinElmer Brownlee analytical C8 column (260 mm x 4.6 mm, 5 µm) using methanol: 50 mM KH2PO2buffer (PH adjusted to 6.8 with 0.1 M NaOH), 80:20 v/v as an eluent. UV detection was performed at 270 nm at a flow rate 1.0 mL/min. The validation of the method was performed, and specificity, reproducibility, precision accuracy and ruggedness were confirmed. The correlation coefficient was found to be 0.997 for atomoxetine hydrochloride. The recovery was in the range of 99.94 to 100.98% and limit of quantification was found to be 5.707 µg/mL. The method is simple, rapid, selective and economical too and can be used for the routine analysis of drug in pharmaceutical formulations.


2019 ◽  
Vol 11 (1) ◽  
pp. 216 ◽  
Author(s):  
Ramya Kuber B.

Objective: To develop a simple, sensitive, specific, accurate reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of curcumin and piperine.Methods: The separation was done using a column Inertsil–ODS C18 (250 mm × 4.6 mm, 5µ particle size) and mobile phase composed of methanol: water (45:55 v/v), flow rate at 1 ml/min and detection was carried out at 282 nm with photodiode array (PDA) detector.Results: The separation of curcumin and piperine were found to be at the retention time of 2.433 min and 3.095 min, respectively. The method was found to be linear at a concentration range 20-80 µg/ml for curcumin and piperine. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.05µg/ml and 0.17µg/ml for curcumin and 0.18µg/ml and 0.53µg/ml for piperine respectively. The average percentage recoveries of curcumin and piperine were in the range of 98-100.6%.Conclusion: A simple and sensitive reverse phase high performance liquid chromatographic method was developed for the estimation of curcumin and piperine.


Author(s):  
SYED IBRAHIM BAJE ◽  
B. JYOTHI ◽  
N. MADHAVI

Objective: The objective of the present study was to develop and validate a novel reverse phase high performance liquid chromatographic (RP-HPLC) method, for simultaneous determination of ritonavir (RIT), ombitasvir (OMB) and paritaprevir (PAR) in bulk mixtures, and in tablets. Methods: Determination of the drugs ritonavir (RIT), ombitasvir (OMB), and paritaprevir (PAR), was carried out applying Hypersil BDS C18 column (250 mm X 4.6 mm i.e., 5 µm particle size), with photodiode array detector at λmax of 254 nm. The mobile phase applied for the current study composed of two solvents, i.e. A (0.01N % w/v potassium di-hydrogen orthophosphate buffer, pH 3.0 adjusted with dilute orthophosphoric acid) and B (acetonitrile). The mobile phase was pumped at a flow rate of 1.0 ml/min in the isocratic mode. The validation study with respect to specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantification (LOQ) was carried out employing the ICH guidelines. Results: Ritonavir, ombitasvir, and paritaprevir showed linearity of response between 12.5-75 μg/ml for ritonavir, 3.125-18.75 µg/ml for ombitasvir and 18.75–112.5 µg/ml for paritaprevir, with a correlation coefficient (R2) 0.999, 0.999,0.999 for RIT, OMB, and PAR respectively. The % recovery obtained was 99.82±0.14 % RIT, OMB 100.03±0.96 % and for 99.96±0.26 % PAR. The LOD and LOQ values for RIT, OMB, PAR were obtained to be 0.02, 0.019and0.02, µg/ml and 0.07, 0.06 and 0.07 µg/ml, respectively. The method also exhibits good robustness for different chromatographic conditions like wavelength, flow rate, mobile phase, and injection volume. Conclusion: The method was successfully employed, for the quantification of RIT, OMB, and PAR, in the quality control of in-house developed tablets, and can be applied for the industrial use.


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