A Stability Indicating Reverse Phase High Performance Liquid Chromatography Method for Simultaneous Estimation of Hydroquinone, Hydrocortisone and Tretenoin in Cream Formulation: A Recent Study

2021 ◽  
pp. 12-26
Author(s):  
Raksha Shilu ◽  
Pankaj Kapupara ◽  
Meghna Patel
2020 ◽  
Vol 10 (4) ◽  
pp. 79-86
Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde

A Simple, precise, and accurate stability-indicating reversed-phase high-performance liquid chromatography method has been established for the simultaneous estimation of rosuvastatin calcium and fenofibrate in combined bulk and tablet formulation. The chromatographic separation was performed on reverse phase Princeton (C18) (250 mm x 4.6 mm, 5µ) column with mobile phase as a mixture of water (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio (40:60) v/v at the flow rate 1.0 ml/min. Detection was carried out at wavelength 240 nm. The retention time under the optimized condition of Rosuvastatin calcium and Fenofibrate was found to be 2.485 & 3.905 minutes respectively. The calibration curve was linear in the range of 6-16 µg/ml and 87-232 µg/ml for rosuvastatin calcium and fenofibrate with a correlation coefficient of 0.9999 and 0.9994 respectively. Relative standard deviation values for all key parameters were less than 2.0%. The percentage recovery was found to be 99.66-100.37% and 99.13-100.44% for rosuvastatin calcium and fenofibrate respectively. The developed reversed-phase high-performance liquid chromatography method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical, and could be used for regular quality control of rosuvastatin calcium and fenofibrate in bulk and tablet formulations.  Keywords: Rosuvastatin calcium, Fenofibrate, RP-HPLC, Method validation, ICH guidelines.


Author(s):  
RASHMI PATIL ◽  
UTTARA JAISWAR ◽  
VANDANA JAIN

Objective: The study aims to develop and validate a novel reverse-phase high-performance liquid chromatographic method for simultaneous estimation of andrographolide and aloe-emodin in herbal formulation and validate as per the International Conference on Harmonization (ICH) guidelines. Methods: The analysis was carried on a Shimadzu LC Prominence-i 2030 model with the Lab Solution software. The column used for separation was Prontosil C18 (250×4.6 mm, 5 μ), with a mobile phase consisting of acetonitrile and 0.05% orthophosphoric acid (45:55), at a flow rate of 1 ml/min, column temperature was maintained at 28°C and effluents were monitored at 225 nm. The injection volume was 10 μl. Results: The retention time of andrographolide and aloe-emodin was found to be 4.57±0.2 min and 12.29±0.2 min, respectively. The markers were resolved using linear responses that were obtained in concentration ranges of 0.5–60 μg/ml with correlation coefficient (r2) of 0.9992 and 0.999 for andrographolide and aloe-emodin, respectively. The precision results were found to be satisfactory, which indicates that the method is precise. The recovery values lie in the range of 98–120% indicating the accuracy of the method. Conclusion: A novel, simple, accurate, precise, and robust reverse-phase high-performance liquid chromatography method was developed for the simultaneous estimation of andrographolide and aloe-emodin. The developed method can be used for analysis of the formulations containing these phytoconstituents.


Author(s):  
Poornima K. ◽  
Channabasavaraj Kp.

<p><strong>Objective: </strong>A new, rapid, selective, precise, accurate and economical, isocratic, reverse phase high-performance liquid chromatography method has been developed for simultaneous estimation of loperamide hydrochloride and tinidazole in bulk and in tablet formulations.</p><p><strong>Methods: </strong>The separation was achieved by using Lithosphere RP C-18, (250 x 4.6 mm, 5 µm) end capped column with a mobile phase containing sodium-1-octane sulfonate buffer: methanol: acetonitrile (40:30:30%v/v/v) pH adjusted to 4.0 (using dilute orthophosphoric acid). The flow rate was 1.0 ml/m and column effluent was monitored at 224 nm. The method was validated as per international conference on chemical harmonization (ICH) guidelines.</p><p><strong>Results</strong>:<strong> </strong>Tinidazole and loperamide hydrochloride were eluted at about 3.1 and 5.4 min respectively, indicating the shorter analysis time. The proposed method was found to be accurate, precise and reproducible. The linearity was established in the concentration range of 10-50 µg/ml. Limit of detection (LOD) and Limit of quantification (LOQ) was found to be 0.001 µg/ml and 0.003 µg/ml for loperamide hydrochloride and 0.01 µg/ml and 0.03 µg/ml for tinidazole.</p><p><strong>Conclusion: </strong>This method can be used for routine analysis of formulations containing any of the above drugs or combinations without any alteration in the chromatographic conditions.</p>


Author(s):  
MEGHA PATEL ◽  
PARESH PATEL ◽  
DHARA PATEL

Objective: A simple, rapid, accurate, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of olanzapine (OLZ) and aripiprazole (APR) in synthetic mixtures. Methods: The stationary phase used for chromatographic separation was Phenomenex C18 column (250 mm × 4.6 mm i.d, particle size 5 μm) and mobile phase used for separation was methanol: Phosphate buffer (pH 3) taken in ratio of 75:25 %v/v. The flow rate was used 1.0 ml/min at room temperature and drugs detected at 240 nm with injection volume 20 μL. Results: The retention time for OLZ and APR was found to be 4.231 and 6.523 min, respectively. The linearity was performed using a concentration range of 0.5–3.0 for both drugs. The correlation coefficient was found to be 0.999 for OLZ and APR. The % purity of both the drug was found to be 98–102%. The proposed RP-HPLC method has been validated, according to International council on harmonization Q2 (B) guidelines. Conclusion: There was no interference of any diluents and excipients in the determination of drugs from synthetic mixture. Hence, the developed method can be used for routine quality control analysis.


Author(s):  
GOMATHY SUBRAMANIAN ◽  
S.N.MEYYANATHAN ◽  
GOWRAMMA BYRAN

Objective: A stability-indicating reverse-phase high-performance liquid chromatographic method was developed and validated for the analysis of apigenin and luteolin. The degradation behavior of apigenin and luteolin was investigated under different stress conditions as recommended by the International Conference on Harmonization (ICH). Methods: In the present study, a reversed-phase high-performance liquid chromatography method was developed and the resolution of the plant constituents was successfully achieved using Hibar Lichrospher C8 column with ultraviolet detector at a wavelength of 269 nm. The mobile phase consisted of methanol and 0.5% trifluoroacetic acid (80:20 v/v) at a flow rate of 1.0 ml/min. Both apigenin and luteolin were subjected to various stress degradation studies such as oxidation, acid and alkaline hydrolysis, and photolytic degradation. Results: The proposed method was found to be linear (1–5 μg/ml) with the linear correlation coefficient of R2=0.99. Although the degradation products of stressed conditions were not identified, the methods were able to detect the changes due to stress condition. Conclusion: The method provides good sensitivity and excellent precision and reproducibility. Forced degradation studies on apigenin and luteolin give information about their storage and intrinsic stability conditions considering the advanced pharmaceutical aspects of formulations.


Author(s):  
Anjoo Kamboj ◽  
Manisha Bhatti ◽  
Pooja Atri

ABSTRACTObjective: Xanthium strumarium is a cocklebur or burweed belonging to family Asteraceae and commonly found as a weed, is widely distributed inNorth America, Brazil, China, Malasia, and hotter part of India. The herb is traditionally used mostly in treating several ailments. The present studydeals with development and validation of a reliable reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneousestimation of Stigmasterol and β-sitosterol in the various extracts of the plant.Methods: The proposed method utilizes a Qualisil Gold C18 column (250×4.6 mm), 5 µm particle size, under isocratic elution conditions with themixture of acetonitrile:ethanol:water (85:14:1 v/v/v) at 25° as a mobile phase. An effluent flow rate of 1 ml/minute and ultraviolet detection at202 nm was used for the analysis of Stigmasterol and β-sitosterol.Results: The described method was linear in the range of range of 100-500 µg/ml and 10-500 µg/ml for stigmasterol and β-sitosterol respectively,with excellent correlation coefficients. The precision, robustness, and ruggedness values were also within the prescribed limits (<2%). The recoveryvalues were within the range, which indicates that the accuracy of the analysis was good and that the interference of the matrix with the recovery ofphytosterols was low. The phytosterols were found to be stable in a stock solution for 24 hrs (percentage relative standard deviation was below 2%)and no interfering extra peaks were observed under controlled stress conditions.Conclusion: The proposed method is simple, specific, precise, accurate, and reproducible and thus can be used as appropriate method for routineanalysis of X. strumarium phytosterols in quality control laboratories.Keywords: Xanthium strumarium, Reverse phase high-performance liquid chromatography method, Precision, Phytosterols, Quality control.


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