Stability-Indicating RP-HPLC Method for Simultaneous Quantification of Ombitasvir, Paritaprevir and Ritonavir in Tablet Dosage Form

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.

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STABILITY-INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND AZILSARTAN MEDOXOMIL IN TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.53.06.10500 ◽

2016 ◽

Vol 53 (06) ◽

pp. 51-61

Author(s):

J. G Modi ◽

◽

J. K. Patel

Keyword(s):

Mobile Phase ◽

Dosage Form ◽

Hplc Method ◽

Simultaneous Estimation ◽

Good Resolution ◽

Amlodipine Besylate ◽

Stability Indicating ◽

Rp Hplc ◽

Tablet Dosage ◽

Azilsartan Medoxomil

A novel, simple, rapid, and highly selective stability indicating RP-HPLC method was developed and validated for simultaneous estimation of azilsartan medoxomil (AZL) and amlodipine besylate HCl (AMLO) in tablet dosage form having strength of 20 mg and 2.5 mg, respectively. The effective chromatographic separation was achieved on a Phenomenex luna ODS C18 (15 cm X 4.6 mm internal diameter, 3.5 μm Particle size) with a mobile phase composed of phosphate buffer (pH-2.5) adjusted with ortho phosphoric acid : acetonitrile in the ratio of 60:40 v/v. The mobile phase was pumped using an isocratic HPLC system at a flow rate of 0.7 mL/min with injection volume 20μl and quantification of the analytes was done at detection wavelength 254 nm. The retention times were found to be 5.918 min and 14.901 min for AMLO and AZL, respectively. The proposed HPLC method was validated with respect to linearity, ranges, precision, accuracy, specificity, robustness, LOD, and LOQ as per ICH Q2 (R1) guideline. Calibration plots were linear over the concentration range of 75-125 µg/mL and 600-1000 µg/mL with correlation coefficients 0.9966 and 0.9948 for AMLO and AZL, respectively. Forced degradation studies were performed using hydrolysis, oxidation, photolytic, and thermal degradation conditions with good resolution between the degradants and analytes. Degradation products resulting from the stress studies did not interfere with the detection of AMLO and AZL, thus the proposed method is sensitive and stability-indicating. The validated HPLC method was successfully applied to the analysis of AMLO and AZL in tablet dosage form.

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Validation of a Stability-Indicating RP-HPLC Method for the Determination of Entecavir in Tablet Dosage Form

Journal of AOAC International ◽

10.1093/jaoac/93.2.523 ◽

2010 ◽

Vol 93 (2) ◽

pp. 523-530 ◽

Cited By ~ 5

Author(s):

Sérgio Luiz Dalmora ◽

Maximiliano da Silva Sangoi ◽

Daniele Rubert Nogueira ◽

Lucélia Magalhães da Silva

Keyword(s):

Dosage Form ◽

Potassium Phosphate ◽

Hplc Method ◽

Forced Degradation ◽

Photodiode Array Detection ◽

Stability Indicating ◽

Rp Hplc ◽

Forced Degradation Studies ◽

Tablet Dosage

Abstract An RP-HPLC method was validated for the determination of entecavir in tablet dosage form. The HPLC method was carried out on a Gemini C18 column (150 4.6 mm id) maintained at 30C. The mobile phase consisted of acetonitrilewater (95 + 5, v/v)/potassium phosphate buffer (0.01 M, pH 4; 9 + 91, v/v) pumped at a flow rate of 1.0 mL/min. Photodiode array detection was at 253 nm. The chromatographic separation was obtained with a retention time of 4.18 min, and the method was linear in the range of 0.5200 g/mL (r2 0.9998). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients and an increase of the cytotoxicity only by the basic condition. The accuracy was 101.19, with bias lower than 1.81. The LOD and LOQ were 0.39 and 0.5 g/mL, respectively. Method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.

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A new validated stability-indicating RP-HPLC method for simultaneous quantification of dolutegravir and lamivudine in bulk and pharmaceutical dosage form

Future Journal of Pharmaceutical Sciences ◽

10.1186/s43094-020-00060-y ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Khaleel Noorbasha ◽

Sharmila Nurbhasha

Keyword(s):

Dosage Form ◽

Hplc Method ◽

Pharmaceutical Dosage Form ◽

Stability Indicating ◽

Simultaneous Quantification ◽

Rp Hplc

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A Validated Stability Indicating RP-HPLC Method for the Estimation of an Anti-Cancer Drug Regorafenib in Pure and Pharmaceutical Dosage Form

JOURNAL OF PHARMACEUTICAL CHEMISTRY ◽

10.14805/jphchem.2017.art70 ◽

2017 ◽

Vol 4 (1) ◽

pp. 5-10 ◽

Cited By ~ 1

Author(s):

Ramesh Jayaprakash ◽

Senthil Kumar Natesan

Keyword(s):

High Performance ◽

Dosage Form ◽

High Performance Liquid Chromatographic ◽

Hplc Method ◽

Cancer Drug ◽

Pharmaceutical Dosage Form ◽

Stability Indicating ◽

Rp Hplc ◽

Tablet Dosage ◽

Liquid Chromatographic

A simple, economic, accurate, sensitive, specific and precise stability indicating reverse phase high performance liquid chromatographic [RP-HPLC] method for the determination of Regorafenib in pure and tablet dosage from was developed and validated. The chromatographic separation was carried out using Phenomenex Luna-C18 column (4.5x250 mm; 5 µm particle size) as a stationary phase and methanol: acetonitrile: water (55:25:20 v/v/v) as a mobile phase. The flow rate of 1 mL/min was used with PDA detection at 275 nm. The retention time of Regorafenib was 2.480 min. RP-HPLC method was developed with linearity range of 40-240 µg/mL of Regorafenib. The correlation coefficient [r2] was found to be 0.9999. The assay results obtained was in good agreement with the corresponding labeled amount by developed method within range of 98.83 ± 0.6937. Accuracy of the method was confirmed by recovery studies and the recoveries were found to be between 99.61 % and 100.22 %, the corresponding %RSD was found to be 0.2029. Precision, LOD, LOQ, specificity, robustness and ruggedness were performed as per ICH Q2(R1) guidelines and were within the acceptance criteria. This method can be conveniently used to detect the possible degradation product in the dosage form of Regorafenib during stability studies (acidic, alkaline, oxidative, thermal and photolytic). The method proved to be effective on the analysis of stressed marketed tablet formulation.

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