scholarly journals Development and Validation of Novel Analytical Simultaneous Estimation Based UV Spectrophotometric Method for Doxycycline and Levofloxacin Determination

2021 ◽  
Vol 12 (4) ◽  
pp. 5458-5478
Keyword(s):  
Solvent System ◽  
Quality Analysis ◽  
Simultaneous Estimation ◽  
Literature Study ◽  
Drug Products ◽  
Ich Guidelines ◽  
Percent Recovery ◽  
Uv Visible ◽  
Development And Validation

The thorough literature study uncovered that none of the most perceived pharmacopeias or any journals includes a method for simultaneous estimation of Doxycycline and Levofloxacin in combination by UV/Visible spectroscopy. So, it was felt fundamental to build up a system that will serve as a solid, precise UV technique for the simultaneous estimation of Doxycycline and Levofloxacin. DOXH and LVXH showed λmax at 273nm and 287nm respectively, and iso-absorptive point at 280nm in Phosphate buffer pH 6.8 prepared in Water: Methanol (80:20) dissolvable solvent system. Beer Lambert's law obeyed by both drugs within the concentration range of 2-20 μg/ml & r2 values of 0.9999 and 0.9998, which shows the good linearity. The method has been validated statistically and quantitatively regarding linearity, precision, LOD, LOQ, accuracy, and specificity according to the ICH guidelines. LOD for DOXH and LVXH were found to be 1.41 and 0.63 μg/ml, the LOQ was 4.30 and 1.92 μg/ml, respectively. Percent recovery at recovery level of 80%, 100% & 120% for DOXH was found to be 99.7, 99.66 & 99.69 & for LVXH 99.58, 99.66 & 99.63 respectively. Intra-day, Inter-day & precision analysis by different analyst was found to be 0.767, 0.563, 0.440 %RSD for DOXH & 0.507, 0.532, 0.708 % RSD for LVXH. Sandell's sensitivity was discovered to be adequate, and this shows that extremely less measure of the two medications can be successfully recognized by this technique. Finally, it was concluded, the developed & validated method was helpful and appropriate for regular quality analysis and simultaneous determination of drug products containing DOXH and LVXH in combination.

scholarly journals DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DULOXETINE

2019 ◽  
pp. 27-31
Author(s):  
LIPSA SAMAL ◽  
AMARESH PRUSTY
Keyword(s):  
Spectrophotometric Method ◽  
Spectroscopic Method ◽  
Solvent System ◽  
Spectrophotometric Analysis ◽  
Thiophene Derivative ◽  
Experimental Conditions ◽  
Relative Standard ◽  
Uv Visible ◽  
Development And Validation

Objective: The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of duloxetine, which is a thiophene derivative and a selective neurotransmitter reuptake inhibitor for serotonin, norepinephrine, and to lesser degree dopamine. Methods: The UV Spectrophotometric analysis was performed using Shimadzu UV-1800 and Shimadzu UV-1700 spectrophotometer by using solvent system acetonitrile and water in the ratio of 8:2. Detection was performed at a wavelength of 290 nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters linearity, accuracy, precision, ruggedness, and robustness, LOD and LOQ. Results: The UV Spectrophotometric method was found linear in the range of 10-50 μg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries were found to be higher than 99% in all experimental conditions. Conclusion: Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and suitable for the determination of Duloxetine for routine analysis.

scholarly journals Absorbance Correction Method for Simultaneous Estimation of Nifedipine and Metoprolol Succinate in Their Synthetic Mixture Using From Spectrophotometry

2015 ◽  
Vol 1 (3) ◽  
pp. 151
Author(s):  
Sojitra Rajanit ◽  
Paras Virani ◽  
Hashumati Raj
Keyword(s):  
Accurate Method ◽  
Correction Method ◽  
Synthetic Mixture ◽  
Simultaneous Estimation ◽  
Metoprolol Succinate ◽  
Absorption Correction ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

A new simple, economical, precise and accurate method are described for the simultaneous determination of Nifedipine (NIF) and Metoprolol Succinate (MET) in combined tablet dosage form. The proposed method was applied for the determination of Nifedipine and Metoprolol Succinate in synthetic mixture, for determination of sampling wavelength, 10?g/ml of each of NIF and MET were scanned in 200-400 nm range and sampling wavelengths were 313nm for NIF and 275.40nm for MET are selected for development and validation of absorption correction method. For this method linearity observed in the range of 5-25?g/ml for NIF and 25-125?g/ml for MET, and in their pharmaceutical formulation with mean percentage recoveries 100.68 and 100.33, respectively. The method was validated according to ICH guidelines and can be applied for routine quality control testing.

Analytical Method Development and Validation of Prucalopride Succinate in Bulk and Formulation by UV-Visible Spectrophotometry

2021 ◽  
pp. 4189-4191
Author(s):  
A.C. Bhosale ◽  
V.C. Bhagat ◽  
V. V Kunjir ◽  
D.P. Kardile ◽  
R.V. Shete
Keyword(s):  
Quantitative Determination ◽  
Spectrophotometric Method ◽  
Analytical Method ◽  
Method Development ◽  
Routine Analysis ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Uv Visible ◽  
Development And Validation

Purpose: Analytical method development and validation for the quantitative determination of Prucalopride succinate in bulk and tablet formulation which plays major role in the development and manufacture of pharmaceuticals. Methods: In the present work a simple, rapid and reproducible UV-Visible Spectrophotometric method was developed and validated according to ICH guidelines. Results and Conclusions: The parameters linearity, specificity, precision, accuracy, and robustness were studied. The wavelength 243nm was selected for the estimation of drug using methanol as a solvent. The drug obeys Beer-lambert’s law over the concentration range 2-10μg/ml. The accuracy of the method was assessed by recovery studies and was found between 97.2- 98.3 %. The method was successfully applied for routine analysis of Prucalopride succinate in bulk and formulation.

scholarly journals Development and Validation of UV-Visible Spectrophotometric Method for the Determination of 5-Hydroxymethyl Furfural Content in Canned Malt Drinks and Fruit Juices in Ghana

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Joseph K. Adu ◽  
Cedric D. K. Amengor ◽  
Emmanuel Orman ◽  
Nurudeen Mohammed Ibrahim ◽  
Maryjane O. Ifunanya ◽  
...  
Keyword(s):  
Ultraviolet Radiation ◽  
Spectrophotometric Method ◽  
Manufacturing Process ◽  
Fruit Juice ◽  
Solvent System ◽  
Maximum Absorption ◽  
Hydroxymethyl Furfural ◽  
Uv Visible ◽  
Development And Validation

A simple, rapid, accurate, and less expensive spectrophotometric method has been developed for the quantitation of 5-hydroxymethyl furfural (5-HMF) levels in canned malt drinks and fruit juice drinks sampled in the Kumasi Metropolis, Ghana. The quantitation is based on the selective maximum absorption of ultraviolet radiation by 5-HMF at the wavelength (λmax) of 284 nm using acetonitrile : water (50 : 50 v/v) as the solvent system. The method was established to be specific, precise, and accurate over a concentration range of 0.001 mg/ml–0.02 mg/ml. 5-HMF levels in fruit juice samples (A1–A10) were between 0.132 mg/ml and 0.438 mg/ml, and these levels were shown to be comparable (t = 2.200;p=0.0553) to the contents in the canned malt samples (M1–M10) which were between 0.3140 mg/ml and 0.7170 mg/ml. The study failed to show any dependence of 5-HMF levels on the composition of the product as well as the manufacturing process adopted. The length of storage did also not significantly affect the 5-HMF levels in the products.

scholarly journals Simultaneous Determination of Piracetam and Citicoline in Combination Drug Products by Rp-Hplc Method

2021 ◽  
pp. 171-185
Author(s):  
Meka. Srinivasa Rao ◽  
K. Rambabu
Keyword(s):  
Hplc Method ◽  
Simultaneous Estimation ◽  
Combination Drug ◽  
Drug Products ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
System Suitability ◽  
Relative Standard

In this paper a simple, accurate and precise RP-HPLC method for the simultaneous. Estimation of piracetam and citicoline in synthetic mixtures has been developed and validated. Separation of drugs was carried out using buffer and Acetonitryle with proportion of 60:40 %v/v as mobile phase at 5 min. run time and 265nm. The Rt value for piracetam and citicoline was found to be 3.158 and 5.196 min respectively. The developed method has been validated for linearity, accuracy and precision, LOD, LOQ, and system suitability according to ICH guidelines. The low values of LOD and LOQ illustrate that the developed method was sensitive, accurate, and precise as it can detected and quantify with very low concentration. The low % RSD values below 2 indicate that the method is precise. The above validation studies revealed the method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of piracetam and citicoline in combined dose products.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous estimation of ceftriaxone and tazobactum in sterile powder for injection

2019 ◽  
Vol 1 (2) ◽  
pp. 40-43
Author(s):  
T. Vimalakkannan ◽  
P. Shaik Parveen ◽  
Salomi ◽  
K. Ravindra Reddy
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Accurate Method ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

A simple, rapid, precise and accurate method is developed for the quantitative simultaneous determination of ceftriaxone and tazobactum in bulk and pharmaceutical formulations. Separation of ceftriaxone and tazobactum was successfully achieved by using Inertsil C18 ODS column 250X4.6mm, 5µm in an isocratic mode using water and acetonitrile (80:20) at a flow rate of 1.0 ml/min and was monitored at 254 nm with a retention time of 3.049 minutes and 4.317 minutes for ceftriaxone and tazobactum respectively. The method was validated and the response was found to be linear in the drug concentration range of 20µg/ml to 80 µg/ml for ceftriaxone and 5 µg/ml to 35 µg/ml for tazobactum. The values of the correlation coefficient were found to be 0.999 for ceftriaxone and 0.999 for tazobactum respectively. The LOD and LOQ for ceftriaxone were found to be 0.021 and 0.064 respectively. The LOD and LOQ for tazobactum were found to be 0.030 and 0.091 respectively. The percentage recovery for ceftriaxone and tazobactum were found to be 98-102% respectively which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.  Stability of the drugs was determined by using acid/base, thermal, oxidative stress testing.

scholarly journals Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Quinfamide and Mebendazole in in-house Pharmaceutical Formulation

2018 ◽  
Vol 6 (1) ◽  
pp. 9-20 ◽  
Author(s):  
Ajinkya G. Dhandar ◽  
Saurabh B. Ganorkar ◽  
Amod S. Patil ◽  
Atul A. Shirkhedkar
Keyword(s):  
Quantitative Determination ◽  
Absorption Maximum ◽  
Dosage Form ◽  
Cost Effective ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Development And Validation

The present work described the development of two simple, accurate, rapid, cost effective and reproducible UV-Spectrophotometric methods for the simultaneous estimation of Quinfamide and Mebendazole in bulk and in laboratory mixture using 0.01M methanolic HCl as a solvent. The absorption maximum for Quinfamide and Mebendazole were found to be at 260.00 nm and 232.40 nm respectively. Beer’s - lamberts was followed in concentration ranges of 1 - 6 μg/mL for Quinfamide and 2- 12 μg/mL for Mebendazole. The percentage recovery of Quinfamide and mebendazole ranged from 98.48 to 99.08 and 98.83 to 99.62 (Method I); from 98.14 to 98.93 and 99.16 to 99.35 (Method II) for Quinfamide and Mebendazole. The established methods were sensible for simultaneous quantitative determination of both these drugs in fixed dose combinations. Validation of both these methods was performed as per ICH guidelines. The developed methods can routinely be used for estimation of both these drugs in their combined dosage form.

scholarly journals Development and Validation of UV-Visible Spectrophotometric Baseline Manipulation Method for Simultaneous Quantitation of Tenofovir Disoproxil Fumarate and Emtricitabine in Pharmaceutical Dosage Form

2013 ◽  
Vol 2013 ◽  
pp. 1-6
Author(s):  
Vishnu P. Choudhari ◽  
Sanket R. Parekar ◽  
Subhash G. Chate ◽  
Pradeep D. Bharande ◽  
Rajiv R. Singh ◽  
...  
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Dosage Form ◽  
Distilled Water ◽  
Difference Spectroscopy ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Uv Visible ◽  
Development And Validation ◽  
Tablet Dosage

A simple, economical, precise, and accurate new UV-visible spectrophotometric baseline manipulation method for simultaneous determination of tenofovir disoproxil fumarate (TE) and emtricitabine (EM) in combined tablet dosage form has been developed. The method is based on baseline manipulation (difference) spectroscopy where amplitudes at 261 and 289.9 nm were selected to determine TE and EM, respectively, in combined formulation, and distilled water was used as solvent. Both drugs obey Beer’s law in the concentration ranges of 4–20 μg/mL for TE and 6–30 μg/mL for EM. The results of analysis have been validated statistically, and recovery studies confirmed the accuracy of the proposed method which was carried out by following the ICH guidelines.

scholarly journals Development and validation of a new analytical RP-HPLC method for simultaneous determination of Glibenclamide and Atenolol in bulk

2019 ◽  
Vol 10 (3) ◽  
pp. 2433-2445
Author(s):  
Anitha P ◽  
Ramkanth S ◽  
Satyanarayana S V
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Development And Validation ◽  
First Time

A new, simple, reliable, fast, sensitive and economical RP-HPLC method was developed and validated for simultaneous estimation of two fixed-dose combinations frequently prescribed in coexisted chronic diseases such as diabetes (GLB) and hypertension (ATN) in bulk for the first time. The mobile phase used for the chromatographic runs consisted of 0.01N potassium dihydrogen ortho phosphate (pH 4.8) and acetonitrile (55:45, v/v). The separation was achieved on column (BDS C18 250 x 2.1mm, 1.6m) using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 235.0 nm. The method was linear at the concentration range 2.5-15µg/ml for Glibenclamide (GLB) and 6.25-37.5µg/ml for Atenolol (ATN), respectively. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The method was validated for system suitability, linearity, accuracy, precision, detection, quantification limits and robustness and was found it is acceptable in the range of 2.5–15 µg/ml for GLB and 6.25–37.5 µg/ml for ATN. The LOD and LOQ of GLB was found to be 0.48 µg/ml and 1.47µg/ml and for ATN was found to be 0.72µg/ml and 2.20 µg/ml, respectively. The method was applied to drug interaction studies of GLB with ATN to illustrate the scope and application of the methods to manage two different therapeutic classes of drugs, as they may co-administered in concurrent diseases.

scholarly journals Development and Validation of RP-HPLC Method for the Determination of Ganciclovir in Bulk Drug and in Formulations

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
P. J. Ramesh ◽  
K. Basavaiah ◽  
K. B. Vinay ◽  
Cijo M. Xavier
Keyword(s):  
Ammonium Acetate ◽  
Reversed Phase ◽  
Hplc Method ◽  
Column Temperature ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Percent Recovery ◽  
Bulk Drug ◽  
Development And Validation

A simple, rapid, accurate, and precise gradient reversed-phase HPLC (RP-HPLC) method has been developed for the determination of ganciclovir (GNC) in pharmaceuticals. Chromatographic separation was carried out on inertsil ODS C18 (4.6 mm  mm, 5.0 μm) LC column using ammonium acetate buffer, sodium salt of hexane sulfonic acid as ion-pairing reagent in 1000 mL water, and acetonitrile (90 : 10) (v/v) as mobile phase at a flow rate of 1.0 mL  and with UV detection at 245 nm at column temperature (30°C). The runtime under these chromatographic conditions was 10 min. The method was linear over the range of 0.02–75 μg . The limits of detection (LOD) and quantification (LOQ) values were 4.1 and 20 ng , respectively. The method was successfully extended to study the effect on GNC upon treatment with 2 N NaOH, 2N HCl, and 5% H2O2 for 2 hrs at 80°C and upon exposure to UV (1200 K lux hrs) for 72 hrs and thermal (105°C) for 5 hrs. The proposed method was further applied to the determination of GNC in pharmaceuticals, with good percent recovery. The accuracy and the precision of the method were validated on intraday and interday basis in accordance with ICH guidelines.

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