DEVELOPMENT AND VALIDATION OF A RP-UFLC ANALYTICAL METHOD FOR THE DETERMINATION OF OPIPRAMOL IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (11) ◽  
pp. 24-28
Author(s):  
S.B Rohith ◽  
◽  
B.M Gurupadayya ◽  
R.S Chandan
Keyword(s):  
Analytical Method ◽  
Potassium Dihydrogen Phosphate ◽  
Dihydrogen Phosphate ◽  
Control Analysis ◽  
Potassium Dihydrogen ◽  
Ich Guidelines ◽  
Fast Liquid Chromatography ◽  
Development And Validation ◽  
Tablet Dosage

A novel ultra-fast liquid chromatography (RP- UFLC) analytical method has been developed to quantify opipramol in tablet formulations. The determination was carried out by means of a Phenomenex Luna C8 Column (250×4.60mm, 5μ); potassium dihydrogen phosphate buffer of pH 2.4 and acetonitrile was used as a mobile phase in the ratio of 60:40 V/V with a flow rate of 1.00 mL/min. The photo diode array (PDA) detector was operated at wavelength of 253nm. The retention time for opipramol was found to be 2.72min. The validation studies were carried out according to ICH guidelines with a specific aim to establish that the new analytical method developed complied with the validation guidelines. The main parameters for validation study are specificity, linearity, accuracy, precision, LOD, LOQ and robustness. This method can be used for quality control analysis of opipramol in pure and marketed formulation.

scholarly journals Development and Validation of RP-HPLC Method for Estimation of Teneligliptin and its Impurity in Tablet

2021 ◽  
Vol 69 (02) ◽  
Author(s):  
Bhoomi Dineshkumar Patel ◽  
Nidhi J. Dharsandiya ◽  
Ankit Chaudhary
Keyword(s):  
Present Method ◽  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Development And Validation ◽  
Tablet Dosage

The objective of the study is a simple, precise and accurate stability RP-HPLC method has been developed and subsequently validated for the estimation of Teneligliptin and its impurity in tablet formulation. The adequate separation was carried out using Grace Smart C18 column (250mm x 4.6mm, 5?m particle size), mixture of 0.05M Potassium dihydrogen phosphate PH 4.0 and Acetonitrile 80:20 % v/v as a mobile phase with a flow rate of 1 ml/min and the effluent was monitored at 242 nm using PDA detector. The retention time of Teneligliptin, Impurity B and Impurity G were 7.443 min, 6.650 min and 8.473 min respectively. Linearity for Teneligliptin, Impurity B and Impurity G were found in the range of 500-3000 µg/ml (R2 = 0.998), 5-15 µg/ml (R2 = 0.994) and 5-15 µg/ml (R2 = 0.998) respectively. The accuracy of the present method was evaluated at 50%, 100% and 150%. The % recoveries of drug were found to be in range of 99.315 ± 0.283 for Teneligliptin. Precision studies were carried out and the RSD values were less than two. The method was found to be robust. The proposed method was found to be specific, accurate, precise and robust can be used for simultaneous estimation of these drugs in tablet dosage form.

scholarly journals A New Stability Indicating RP-HPLC Method for Determination of Chlorthalidone, Telmisartan and Cilnidipine in Bulk and Tablet Dosage Form

2020 ◽  
Vol 13 (1) ◽  
pp. 44-51
Author(s):  
S.Afreen Sultana ◽  
Patta. Salomi ◽  
T. VimalakKannan ◽  
K.Ravindra Reddy
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage

In present study, accurate, precise, rapid and sensitive stability indicting HPLC-UV method has been established for quantification of Telmisartan, Cilnidipine and Chlorthalidone simultaneously in Tablet and bulk. Telmisartan, Cilnidipine and Chlorthalidone were resoluted on Sunsil C18 column (4.6mmx250mm; 5μm) using mobile phase containing Acetonitrile and Potassium dihydrogen phosphate in 50:50(v/v) ratio with flow rate of 1ml/min at 238 nm. Concentrations were linear over the range of 40-120 μg/ml for Telmisartan, 10-30 μg/ml for Cilnidipine and 6.25-18.75 μg/ml for Chlorthalidone. The percentage recovery was found to be 99.70-100.51% for Telmisartan, 98.41-100.49% for Cilnidipine and 99.34-100.48% for Chlorthalidone. % RSD for peak area was 0.069% for Telmisartan, 0.058% for Cilnidipine and 0.057% for Chlorthalidone shows that the proposed method is precise. Force-degradation studies have not shown any observable change in the results and hence the proposed method is stability indicating and hence the method is suitable for routine analysis of Telmisartan, Cilnidipine and Chlorthalidone in bulk and tablet dosage form.

scholarly journals Efficient Validated HPLC/UV Method for Determination of Valsartan and Atenolol in Dosage Form And In Vitro Dissolution Studies

2020 ◽  
Vol 10 (6) ◽  
pp. 6669-6675
Keyword(s):  
Potassium Dihydrogen Phosphate ◽  
In Vitro Dissolution ◽  
Dihydrogen Phosphate ◽  
Uv Detector ◽  
Potassium Dihydrogen ◽  
Dissolution Studies ◽  
Ich Guidelines ◽  
Isocratic Mode

The main purpose of this study was to develop and validate an efficient HPLC/UV method for determination of valsartan and atenolol and to introduce the dissolution profiles of tablets; The resolution of peaks was best achieved with Zorbax C8 (4.6 mm i.d. X 150 mm, 5 μm) column. Samples were chromatographed in a isocratic mode (methanol and 25 mM solution potassium dihydrogen phosphate pH 7.3 (55:45, V/V)), pumped with 1.0 mL/min at 40 °C set temperature of column oven, with UV detector set to 225 nm wavelength; The total chromatographic run time was 6 minutes. The retention time of valsartan is 1.753 min, atenolol – 3.064 min. Linearity was examined and proven at different concentration levels in the range of working concentration of valsartan ( 0.16-0.96 mg/mL) and atenolol (0.2–1.2 mg/mL). The high value of recoveries obtained for valsartan and atenolol indicates that the proposed method was found to be accurate. In all three dissolution media the releases of valsartan and atenolol are more than 85% in 15 min A rapid, simple, accurate, selective, and sensitive method was developed for the determination of valsartan and atenolol in dosage forms. The method was strictly validated according to the ICH guidelines. Acquired results demonstrate that proposed strategy can be effortlessly and advantageously applied for routine quality control of drugs and in vitro dissolution study.

scholarly journals Analytical method development and validation of Amlodipine besylate in tablet dosage form

2019 ◽  
Vol 9 (4-A) ◽  
pp. 463-466
Author(s):  
Sunil Kumar ◽  
Bigan Ram
Keyword(s):  
Analytical Method ◽  
Mobile Phase ◽  
Method Development ◽  
Amlodipine Besylate ◽  
Ich Guidelines ◽  
System Suitability ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

The  accurate and precise HPLC analytical method validated for the determination of Amlodipine besylate  in pharmaceutical dosage form.The chromatographic separation is carried out on shimadzu HPLC system (LC-2010 CHT)  with  UV Vissible  detector and C18(150mm x3.9 mm) 5 μm Column. The Mobile phase consists of Acetonitrile: Methanol: PH 3.0 Buffer (15 V: 35 V: 50 V) , at the flow rate  of  1.0 ml/min and elutes were monitoring  at 237 nm. The observed retention time for Amlodipine besylate was 10.8 min. The % RSD for system precision was 0.41 % and Method precision was 0.58 %.  The method was found to linear (R=0.99996) in the Concentration range of 35-105 μg/ml (50 to 150%). The accuracy was in between 99.50-99.91%. Keywords:  HPLC, Correlation coefficient, System suitability, Bias, % RSD and ICH guidelines

scholarly journals DEVELOPMENT AND VALIDATION OF METHODS FOR QUANTITATIVE DETERMINATION OF ACTIVE PHARMACEUTICAL SUBSTANCES IN NASAL SPRAY

2021 ◽  
Vol 9 (4) ◽  
pp. 266-277
Author(s):  
M. V. Larskiy ◽  
A. E. Pozdnyakova ◽  
Z. D. Khadzhieva ◽  
D. I. Pozdnyakov
Keyword(s):  
Quantitative Determination ◽  
Nasal Spray ◽  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
Dihydrogen Phosphate ◽  
Active Pharmaceutical Ingredients ◽  
Potassium Dihydrogen ◽  
Pharmaceutical Ingredients ◽  
Development And Validation

Intranasal administration of H1-histamine receptor blockers may be a promising approach to the treatment of allergic rhinitis. Earlier, an original composition of a nasal spray containing fexofenadine hydrochloride and ammonium glycyrrhizinate and demonstrating a high level of therapeutic efficacy, was developed.The aim of the study was to develop and validate a method of the quantitative determination of active pharmaceutical ingredients fexofenadine hydrochloride and ammonium glycyrrhizinate in a spray for intranasal administration.Materials and methods. During the development and validation of the method of the fexofenadine hydrochloride and ammonium glycyrrhizinate quantitative determination in a nasal spray, the method of high performance liquid chromatography was used: a Dionex Ultimate 3000 UV chromatograph with a Luna C18 column (2) containing octadecylsilicagel with a 5 μm grain size as a sorbent. The analysis and validation procedures were performed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, the XIVth edition.Results. The study showed that for the simultaneous quantitative determination of fexofenadine hydrochloride and ammonium glycyrrhizinate, the optimal elution regime is a gradient mode with a mobile phase containing 50 mmol/L potassium dihydrogen phosphate solution with methanol (45:55), which ensured the separation of the components in the 20 minutes interval. The validation procedures showed that the developed methodology correspond to all the criteria of validity in terms of the following indicators: correctness, precision, specificity and linearity in the analytical area.Conclusion. The obtained results indicate the possibility of using the method of high-performance liquid chromatography in a gradient elution mode with a mobile phase of the composition of a 50 mmol/L solution of potassium dihydrogen phosphate with methanol (45:55) for the simultaneous quantitative determination of active pharmaceutical ingredients – fexofenadine hydrochloride and ammonium glycyrrhizinate as parts of a promising nasal spray for the allergic rhinitis treatment.

scholarly journals Development and validation of a reversed-phase HPLC method for determination of assay content of Teriflunomide by the aid of BOMD simulations

2021 ◽  
pp. 281-294 ◽  
Author(s):  
Abolghasem Beheshti ◽  
Zahra Kamalzadeha ◽  
Monireh Haj-Maleka ◽  
Meghdad Payaba ◽  
Mohammad Amin Rezvanfar ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Active Pharmaceutical Ingredient ◽  
Reversed Phase ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Td Dft ◽  
High Level ◽  
Development And Validation

Due to the new hopes for treatment of multiple sclerosis (MS) diseases by Teriflunomide (TFN), in this project, a cheap, robust, and fully validated method has been developed both for determination of assay content in API (active pharmaceutical ingredient), and for related impurities analysis (RIA). To operate the method, a common C18, end-capped (250 × 4.6) mm, 5µm liquid chromatography column, was applied. The mobile phase A was prepared by dissolving 2.74 g (20mM) of PDP (potassium dihydrogen phosphate) and 3.72 g (50mM) of PC (potassium chloride) in water (1000 mL). Then, pH was adjusted to 3.0 by adding OPA (ortho-phosphoric acid) 85%; while, the mobile phase B was acetonitrile (ACN) (100%). In order to confirm the experimental data about the λmax of TFN, we have used the Born-Oppenheimer molecular dynamics (BOMD) simulations, quantum mechanics (QM), and TD-DFT calculations. According to the results, the method showed a high level of suitability, specificity, linearity, accuracy, precision, repeatability, robustness, and reliable detection limit.

REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF REGORAFENIB IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 63-68
Author(s):  
R. Raut ◽  
◽  
A. Patil ◽  
V. K Munipalli ◽  
M. Patel ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Control Analysis ◽  
Reverse Phase ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mm× 4.6mm id, 3μ) column with mobile phase consisting of Trifluoroacetic acid (0.2% v/v) and Acetonitrile in the ratio of (50: 50 v/v) at 400C in an isocratic mode was used. The detection was carried out at 260 nm and 20μL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 μg/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.

DEVELOPMENT OF LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF BROMHEXINE HYDROCHLORIDE AND ENROFLOXACIN IN FORMULATIONS

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (02) ◽  
pp. 44-49
Author(s):  
P Choksi ◽  
◽  
F. Shaikh ◽  
D. A. Shah ◽  
K. Agarwal ◽  
...  
Keyword(s):  
Potassium Dihydrogen Phosphate ◽  
Fixed Dose ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Liquid Chromatographic Method ◽  
Dose Combination ◽  
Reproducible Method ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A simple, specific, accurate, precise and reproducible method has been developed and validated for the estimation of bromhexine hydrochloride and enrofloxacin in fixed dose combination using RP-HPLC. The separation was achieved using stationary phase ODS Hypersil C18 column (250 mm× 4.6 mm i.d.) in isocratic mode, with mobile phase containing 0.05 M potassium dihydrogen phosphate buffer (pH 4 by o-phosphoric acid) : methanol: acetonitrile : triethylamine (40:20:40:01), at a flow rate of 1.0mL/min and eluents were monitored at 256 nm. The retention time of enrofloxacin and bromhexine HCl were found to be 3.00 min and 5.1 min respectively. The linearity for bromhexine HCl and enrofloxacin was in the range of 2-15 μg/mL and 20-150 μg/mL, respectively. The method was validated as per ICH guideline. The recoveries of bromhexine HCl and enrofloxacin were found in the range of 99.61-101.65% and 99.52-100.13 %, respectively. The method was successfully applied for the determination of both the drugs in combined dosage form.

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.

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