scholarly journals A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Phoebe Esinam Goku ◽  
Emmanuel Orman ◽  
Anna Naa Kwarley Quartey ◽  
Joseph Kwasi Adu ◽  
Reimmel Kwame Adosraku
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Ammonium Acetate ◽  
Dosage Forms ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Quantification ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Isocratic Mode

An accurate and rapid reverse HPLC method has been developed and validated for the simultaneous quantification of lamivudine, nevirapine, and tenofovir disoproxil fumarate. Suitable separation was achieved on Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) using mobile phase, methanol (50%): ammonium acetate buffer (adjusted to pH 2.80) (40%): acetonitrile (10%) in an isocratic mode. The drugs were detected at 270 nm with a flow rate of 1.0 ml/min, and the retention times were found to be 3.26, 5.42, and 7.55 minutes for lamivudine, nevirapine, and tenofovir disoproxil fumarate, respectively. The developed method was validated per ICH guidelines. Good linearity was obtained within the concentration ranges of 10–59 µg/ml, 7–42 µg/ml, and 15–90 µg/ml with a correlation coefficient of not less than 0.990. The % RSD values for precision (intraday and interday) and accuracy studies were found to be less than 2%. The results obtained from quantitative analysis conform to USP content requirements for marketed tablet dosage forms, RICOVIR-LN, and tenofovir disoproxil fumarate/lamivudine tablets. The method is therefore useful for routine quality control of antiretroviral tablet dosage forms containing tenofovir disoproxil fumarate, lamivudine, and nevirapine.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF EDOXABAN TOSYLATE IN TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (07) ◽  
pp. 47-51
Author(s):  
B. Anupama ◽  
P. Tejaswi ◽  
KNV. Chenchu Lakshmi ◽  
A. Vishwanadh
Keyword(s):  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Isocratic Mode

A rapid, simple and precise reversed phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of edoxabantosylate in tablets. The quantification was carried out using a Phenomenex C-18 column (250×4.6 mm i.d., 5µm particle size) in isocratic mode with mobile phase comprising of ammonium acetate buffer andacetonitrile in the ratio of 50:50 (V/V) at a flow rate 1 mL/min. The eluent was monitored at 240 nm. The retention time of the drug was 3.486 min. The calibration curve was linear in the concentration range of 5-25 µg/mL and per cent recovery ranged from 98.25-101.6.The developed method was validated as per ICH guidelines and the results obtained were satisfactory.The method can be applied for routine quality control analysis of edoxabantosylate in tablet dosage forms.

scholarly journals Method development and method validation of guaifenesin and dextromethorphan by RP-HPLC

2018 ◽  
Vol 1 (1) ◽  
pp. 18-24
Author(s):  
P. Salomi ◽  
D. Mahendra Nayak ◽  
T. Vimalakannan ◽  
K. Ravindra Reddy
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Isocratic Mode ◽  
Good Percentage

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Guaifenesin and Dextromethorphan was successfully achieve THERMO, C18, 250X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1M KH2PO4: Methanol (60:40) at a flow rate of 1.0ml/min and eluate was monitored at 280nm, with a retention time of 3.259 and 4.164 minutes for Guaifenesin and Dextromethorphan respectively. The method was validated and there response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Guaifenesin and 50µg/ml to150 µg/ml for Dextromethorphan. The values of the correlation coefficient were found to 0.999 for Guaifenesin and 1for Dextromethorphan. respectively. The LOD and LOQ for Guaifenesin were found to be 0.597 and 1.991 respectively. The LOD and LOQ for Dextromethorphan were found to be 0.1072 and 0.3572 respectively. This method was found to be good percentage recovery for were found to be 99 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.

scholarly journals A new stability-indicating RP-HPLC method for the determination of dicyclomine hydrochloride and dimethicone combination in tablet dosage forms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
J. Saroja ◽  
Anantha Lakshmi P.V. ◽  
Y. Rammohan ◽  
D. Divya Reddy
Keyword(s):  
Liquid Chromatography ◽  
Dosage Forms ◽  
Flow Speed ◽  
Hplc Method ◽  
Stability Indicating ◽  
Simultaneous Quantification ◽  
Rp Hplc ◽  
Tablet Formulations ◽  
Tablet Dosage

Abstract Background We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. Individual quantification of DEH and DEC was reported. But simultaneous quantification of DEH and DEC was lacking. DEH and DEC were analysed on an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” with the mobile phase solvent run isocratically with 0.1M K2HPO4-acetonitrile (55:45, v/v) on a flow speed of 1.0 mL/min. Results The chromatographic run period for the DEC and DEH assay was 6.0 min with retention times of 2.134 and 2.865 min, respectively. The method was validated for accuracy (99.453 to 100.417% and 99.703 to 100.303% recovery values for DEH and DEC, respectively), precision (RSV value 0.135% for DEC and 0.171% for DEH), linearity (5–15 μg/mL for DEH and 20–60 μg/mL for DEC), selectivity (no hinderance from excipients) and specificity (no hinderance from degradants) recovery. Conclusion The developed stability-indicating liquid chromatography process was well applied to established tablet formulations.

scholarly journals Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

2017 ◽  
Vol 2 (03) ◽  
pp. 41-45
Author(s):  
Sireesha D ◽  
Sai Lakshmi E ◽  
Sravya E ◽  
Vasudha Bakshi
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Room Temperature ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Isocratic Mode

A new simple, rapid, specific, accurate, precise and novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the estimation of Sitagliptin Phosphate in the pharmaceutical dosage form. The chromatographic separation for Sitagliptin was achieved with mobile phase containing methanol, Thermoscientific C18 column, (250x4.6 particle size of 5μ) at room temperature and UV detection at 248 nm. The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Sitagliptin was 1.91min. The above method was validated in terms of linearity, accuracy, precision, LOD and LOQ in accordance with ICH guidelines.

scholarly journals Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Cinacalcet Hydrochloride in Bulk and Their Formulations

2020 ◽  
Vol 10 (6) ◽  
pp. 6610-6618
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Cinacalcet Hydrochloride ◽  
Development And Validation ◽  
Tablet Dosage

A Simple, selective, accurate, precise, linear, and stability-indicating RP-HPLC method was developed and validated for the estimation of Cinacalcet hydrochloride in bulk and tablet dosage forms. Chromatographic separation was achieved on X-Terra Symmetry C18 (4.6 x 150mm; 5 m) with mobile phase containing Phosphate buffer: Acetonitrile (40:60 v/v) pH adjusted to 3.0 ±0.05 with diluted ortho-phosphoric acid. The flow rate was maintained at 0.9 mL/min. The eluent was monitored at 282 nm. Moreover, the retention time of Cinacalcet was 2.8 minutes. The method was validated for linearity, accuracy, precision, and robustness as per ICH guidelines. The developed method was found linear between 25-150 μg/ml, and the linear regression coefficient was 0.999. The % RSD values are less than 2 % indicating the accuracy and precision of the method. The percentage of recovery was obtained from 98-102%. The system suitability parameters were found to be within the limit. Forced degradation studies were conducted under various conditions. The proposed method is simple, rapid, precise, and accurate. It can be used for the quantitation of Cinacalcet hydrochloride in bulk and commercial pharmaceutical dosage forms.

scholarly journals VALIDATED GRADIENT STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS QUANTIFICATION OF 11 RELATED SUBSTANCES IN THE COMBINED DOSAGE FORMS OF LAMIVUDINE AND TENOFOVIR DISOPEOXIL FUMARATE

2017 ◽  
Vol 9 (4) ◽  
pp. 61 ◽  
Author(s):  
C. Babu ◽  
N. Devanna ◽  
K. V.n. Suresh Reddy
Keyword(s):  
Mobile Phase ◽  
Ammonium Acetate ◽  
Dosage Forms ◽  
Hplc Method ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Simultaneous Quantification ◽  
Related Substances ◽  
Drug Substances ◽  
Rp Hplc

Objective: Development of a stability-indicating reverse phase liquid chromatographic (RP-HPLC) method for the simultaneous quantification of 11 impurities in the combined dosage forms of lamivudine and tenofovir disoproxil fumarate drug substances.Methods: Efficient chromatographic separation of all analytes was achieved on a Waters X-terra RP18 column (150 x 4.6 mm, 3.5 mm) using mobile phase A (ammonium acetate buffer, pH adjusted to 5.0±0.05 with dilute orthophosphoric acid) and mobile phase B (mixture of methanol and ammonium acetate buffer in the ratio of 20:80) with the flow rate of 1.0 ml/min in gradient elution mode at 260 nm.Results: The method was validated in terms of the limit of detection, limit of quantification, linearity, accuracy, precision and robustness according to the international conference on harmonisation (ICH Q2R1). Regression analysis showed that the correlation coefficient (r2) is greater than 0.997 for individual active drug substances as well as their related substances. The method has proven very accurate (94.6 % to 108.2 % with % RSD not more than 4.9), highly precise (% RSD of the Intra-day and the inter-day study was not more than 8.9) and robust enough to deliver accurate results, when the chromatographic conditions were altered intentionally. Forced degradation studies were conducted in acidic, basic, thermal, photolytic, humid and peroxide stress conditions, where all the degradation peaks were monitored. Highest degradation of lamivudine was observed under oxidative stress condition and tenofovir was more susceptible to degradation under acidic and alkaline conditions.Conclusion: The present method is able to separate all the related compounds with each other and with the main drug substances with the resolution more than 2.0. The test solution was found to be stable in diluent up to 24 h. The mass balance of forced degradation of formulations, close to 99 %, made this method as a stability indicating method.

scholarly journals Validated RP-HPLC Method for the Determination of Mycophenolate Mofetil in Tablet Dosage Forms

2013 ◽  
Vol 25 (8) ◽  
pp. 4788-4790
Author(s):  
T. Vijaya Bhaskara Reddy ◽  
G. Ramu ◽  
M. Sravan Kumar ◽  
C. Rambabu
Keyword(s):  
Mycophenolate Mofetil ◽  
Dosage Forms ◽  
Hplc Method ◽  
Rp Hplc ◽  
Tablet Dosage
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