Application of an Eco-friendly, Cost-effective Hydrotropic solution as mobile phase for the estimation and validation of Ornidazole in bulk and Pharmaceutical Formulation by RP-HPLC

2021 ◽  
Vol 11 (1) ◽  
pp. 15-21
Author(s):  
L. S. Remi ◽  
Joyamma Varkey ◽  
A. Jayakumaran Nair ◽  
Vishnu. S. Sanjeev
Author(s):  
MD. Muzaffar -ur- Rehman1 ◽  
G. Nagamallika

A simple, rapid, precise, and accurate RP-HPLC method for the estimation of Ivabradine Hydrochloride an anti-anginal agent, both as a bulk drug and in pharmaceutical formulation was developed. The chromatographic separation was achieved on a Thermosil C18 150 × 4.5 mm, 5μm column by using a mobile phase containing a mixture of methanol and phosphate buffer pH 6.5 in the ratio of 65:35 % v/v at a flow rate of 1ml/min and at an ambient temperature. The detection was monitored at a wavelength of 265nm. A clear chromatographic peak was identified with the retention time of 4.36 min and tailing factor of 1.23. The developed method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method shows a good linear relationship with correlation co-efficient of more than 0.992 in the concentration range of 30μg-150μg. The method showed mean % Recovery of 100.4% and %RSD for repeatability and intermediate precision was less than 2%. The proposed method can be used successfully for the quantitative determination of Ivabradine HCL in pharmaceutical dosage forms.


Author(s):  
Sudipta Chakraborty ◽  
N. N. Bala ◽  
Sudipta Das

Aims: The present investigation is aimed at the identification and quantification of flavonoids in the methanol extract of leaves of Bauhinia acuminata Linn. (Caesalpiniaceae) by a validated HPTLC method and confirmation of the same by RP-HPLC. Methodology: CAMAG HPTLC system with VisionCATS software and HPLC Agilent Infinity 1260 were employed for the study. Pre-coated silica gel 60 F254 plates were used as stationary phase and Toluene : Ethyl acetate : Formic acid (5:4:0.2, v/v/v) was used as mobile phase in HPTLC while in HPLC Thermo hypersil BDS C18 column and Methanol and 0.4% Phosphoric acid (65 : 35) were used as stationary and mobile phase respectively. Results: Among different standards used in HPTLC, only quercetin was found to be present and further quantitatively analyzed. The method shows good correlation coefficient (R2 ≥ 0.99) and linearity in the range of 0.5 to 5.0 µg/band.  The concentration of quercetin in the test extract was found to be 0.514 µg/mg of the extract. The LOD and LOQ values were 0.84 µg/band and 2.59 µg/band respectively. The RP-HPLC study also represented good %  RSD of Retention time (0.025) and Area (0.09) which signifies the high precision and repeatability. The assay result (4.99 %) also indicated good presence of the quercetin in the extract. Conclusion: The methods were rapid, cost effective and may be employed for quality-control and standardization of quercetin in different plant extracts.


INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (06) ◽  
pp. 49-59
Author(s):  
Hemant Kumar T ◽  
◽  
Gowri Sankar D ◽  

A simple, specific, accurate, precise and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of metformin HCl and canagliflozin in pharmaceutical formulation. The method was developed using the Altima C8 column (150 ×4.6 mm, 0.5 μm) with a mobile phase consisting of acetonitrile and 0.1 % orthophosphoric acid in water (62:38 %V/V) with a flow rate of 1 mL/min. Detection was carried out at 254 nm using a PDA detector. The retention time for metformin HCl and canagliflozin was found to be 2.282 and 3.339 min, respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was observed over a concentration range 15-225 μg/mL for metformin HCl (r2 =0.9995) and 5-40 μg/mL for canagliflozin (r2 =0.9988). The % RSD for intraday and interday precision was found to be 0.13 and 0.20 for metformin HCl and 0.18 and 0.20 for canagliflozin. The LOD and LOQ were found to be 0.16 μg/mL and 0.54 μg/mL for metformin HCl and LOD and LOQ were found to be 0.05 and 0.21 μg/mL for canagliflozin. Metformin HCl and canagliflozin were subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis.


2015 ◽  
Vol 69 (6) ◽  
pp. 679-687 ◽  
Author(s):  
Zika Cvetkovic ◽  
Vesna Nikolic ◽  
Ivan Savic ◽  
Ivana Savic-Gajic ◽  
Ljubisa Nikolic

New, simple, cost effective, accurate and reproducible RP-HPLC method was developed and validated for the quantification of trans-resveratrol in the extracts of grape exocarp and seeds. The method has proved to be simpler and faster than available methods. Methanol was used as a mobile phase with a flow rate of 1.0 cm3 min-1, while the quantification was effected at 306 nm. The separation was performed at 35?C using a C18 column. The results showed that the peak area response was linear in the concentration range of 1-40 ?g cm-3. The values of LOD and LOQ were found to be 0.125 and 0.413 ?g cm-3, respectively. The antioxidant activity of the extracts was determined using DPPH assay. The ability of DPPH radicals inhibition decreases in the following order: the extract of grape exocarp > trans-resveratrol standard > the extract of grape seeds.


2014 ◽  
Vol 97 (3) ◽  
pp. 791-797 ◽  
Author(s):  
Hiral Soni ◽  
Charmy Kothari ◽  
Deepak Khatri ◽  
Priti Mehta

Abstract Validated RP-HPLC, HPTLC, and UV spectrophotometric methods have been developed for the simultaneous determination of atorvastatin calcium (ATV) and olmesartan medoxomil (OLM) in a pharmaceutical formulation. The RP-HPLC separation was achieved on a Kromasil C18 column (250 × 4.6 mm, 5 μm particle size) using 0.01 M potassium dihydrogen o-phosphate (pH 4 adjusted with o-phosphoric acid)–acetonitrile (50 + 50, v/v) as the mobile phase at a flow rate of 1.5 mL/min. Quantification was achieved by UV detection at 276 nm. The HPTLC separation was achieved on precoated silica gel 60F254 plates using chloroform–methanol–acetonitrile (4 + 2 + 4, v/v/v) mobile phase. Quantification was achieved with UV detection at 276 nm. The UV-Vis spectrophotometric method was based on the simultaneous equation method that involves measurement of absorbance at two wavelengths, i. e., 255 nm (λmax of OLM) and 246.2 nm (λmax of ATV) in methanol. All three methods were validated as per International Conference on Harmonization guidelines. The proposed methods were simple, precise, accurate, and applicable for the simultaneous determination of ATV and OLM in a marketed formulation. The results obtained by applying the proposed methods were statistically analyzed and were found satisfactory.


2009 ◽  
Vol 6 (2) ◽  
pp. 469-474 ◽  
Author(s):  
Zaheer Ahmed ◽  
B. Gopinath ◽  
A. Sathish Kumar Shetty ◽  
B. K. Sridhar

A rapid and sensitive RP-HPLC method with UV detection (262 nm) for routine analysis of adefovir dipivoxil in bulk and in pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of acetonitrile and phosphate buffer (50:50, v/v) with flow rate 1.0 mL min-l. In the range of 5.0-100 µg/mL, the linearity of adefovir dipivoxil shows a correlation co-efficient of 0.9999. The proposed method was validated by determining sensitivity accuracy, precision, robustness stability, specificity, selectivity and system suitability parameters.


Author(s):  
Roshani Singh ◽  
Omray L K ◽  
Pushpendra Soni

In this article “new cost-effective RP-HPLC method development and validation for quantitative estimation of ivacaftor in the pharmaceutical formulation” developed. This study includes RP-HPLC Spectrophotometric method development, such as economical and simple HPLC method was optimized during development and validated accordingly in tablets of ivacaftor. The developed method may utilize for the analysis of ivacaftor at the laboratory level. The result shows that developed methods are cost-effective, rapid (Short retention time), simple, accurate (the value and %RSD between 2-5), precise, and can be used for the intended purpose on the tablet dosage form. The present proposed method is capable of better separation of analyte and qualifies on the point of analytical validation such as linearity, specificity, accuracy, precision, robustness, LOD, and LOQ on a marketed formulation. The simplicity, rapidity, and reproducibility of the developed method qualify the objective of the research. Results of analysis of the ivacaftor tablet formulations are arranged in the experimental, result, and discussion section. The portion of ivacaftor found in terms of quantity was between 98-102% and also within USP 29 chapter (541) acceptance criteria.


2020 ◽  
Vol 10 (6) ◽  
pp. 120-132
Author(s):  
V. M. Bhalme ◽  
P. P. Jumade ◽  
Ram D Bawankar ◽  
D. S. Wanjari ◽  
D. R. Mundhada

Objective: Method development, validation & stability indicating studies for simultaneous estimation of Anti-Hypertensive drugs, Benidepine (BEN) and Metoprolol (MET) from pharmaceutical formulation by RP-HPLC. Methods: For present work, reverse phase chromatography was selected as its suggested use for ionic and moderate to non-polar compounds. Reverse phase chromatography is simple, suitable, better regarding efficiency, stability, and reproducibility. C18 packed column, a 100 X 2.1mm. ID column of 5.0 μm particle packing, was selected for separation of BEN and MET. Different solvent systems were tried and optimized in combinations as mobile phase. BEN (4 μg/ml) and MET (50 μg/ml) in 15mM ammonium formate-Methanol (15:85 v/v) was developed as it was showing good peak shapes and a significant amount of resolution. The mobile phase was flowed at 1.2 ml/min with detection of BEN analytes at 236 nm and MET analytes at 225 nm respectively. Result: Method development was done. Specificity, linearity, accuracy, precision, robustness, limit of detection and limit of quantitation were used to accomplish validation. The method was found linear from 32.5 – 500 µg.ml-1 for both BEN and MET individually. The percentage recovery of BEN when placed for period of 12 hours was found to 100% in 0.1N/M NaOH at 60˚C and Thermal (60˚C); 12 % degradation in 0.1N/M HCl at 60˚C; Oxidation (3-6% H2O2) at room temperature whereas for MET was 100 % in 0.1N/M NaOH, 0.1N/M HCl at 60˚C, at thermal (60˚C) as well as oxidation by 3-6% H2O2 at room temperature.  Conclusion: Developed analytical method for the simultaneous estimation of Benidipine (BED) and Metoprolol (MET) in both bulk and tablet formulation has obliged the ICH guidelines including, tailing factor (T), separation factors (α), theoretical plates (N), capacity factor (k’), resolution (R) and RSD (%). The validated stress degradation studies under thermal, oxidative, alkali and acid ascertained few degradation products for Benidipine whereas the Metoprolol was unaffected with forced degradation studies. Keywords: Benidipine, Metoprolol, Reverse-Phase High Performance Liquid Chromatography, Stability indicating method.


Author(s):  
P. Ravi Sankar ◽  
Viswanath A. ◽  
Eswarudu M.M. ◽  
Divya B. ◽  
Neelima K. ◽  
...  

A sensitive, rapid, precise, accurate high-performance liquid chromatographic method was developed for the estimation of Sorafenib (SOR) in the tablet dosage form. Chromatographic separation of SOR was carried out utilizing thermo-scientific model C18 column (4.6 mm i.d. X 250 mm; 5µm particle size) (based on 99.99 % ultra-high purity silica) using mobile phase that consisting of acetonitrile: methanol (40:60 v/v) at a flow rate of 1.0 mL/min. The absorption maximum (?max) of SOR in the mobile phase was found to be 265.5 nm. It had a retention time of 3.223 min. The calibration curve was in linear function of the drug in the concentration range of 2-10 µg/mL (r2 = 0.999) for the optimized method. The regression equation for SOR was found to be Y = 68228 x + 8071. The Detection Limit (DL) & Quantitation Limit (QL) results of SOR were found to be 0.526 µg/mL and 1.594 µg/mL respectively. The developed method was validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98 - 102 %, and minimum values of % RSD indicate the accuracy of the method. The detailed quantitative results of the study show that this method is precise, accurate, and cost-effective. Thus, the developed RP-HPLC method can be successfully feasible for the routine quality control analysis of SOR in a pharmaceutical dosage form.


Sign in / Sign up

Export Citation Format

Share Document