scholarly journals A Novel Ultra Performance Liquid Chromatographic Method for the Estimation of Lercanidipine in Bulk and Tablet Dosage Form

2021 ◽  
pp. 768-776
Author(s):  
Satyabrata Sahu ◽  
U. Sunila Kumar Patra ◽  
Pratap Kumar Patra
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Ultra Performance Liquid Chromatography ◽  
Stability Study ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Bulk Drug ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Aim: In this present study an accurate reverse phase ultra-performance liquid chromatography (RP-UPLC) method has been developed, validated and applied to stability indicating studies to determine Lercanidipine HCL in bulk and marketed dosage form. Methods: Optimized chromatographic conditions were achieved by using Waters Acquity BEH C18 (2.1 x 50mm, 1.7m) UPLC column. Empower 2 is a software, dihydrogen Orthophosphate Buffer : Methanol (40 : 60)  as eluent at flow rate 0.3 ml/min. PDA detection was performed at 254nm. Results: The developed method was validated and stability study was conducted as per ICH guidelines. The retention time was found at 0.503 min. The method shows linearity over a range of 1 μg/ml to 60 μg /ml with the obtained correlation coefficient is 0.999. The LOD and LOQ values were found 0.025 and 0.05 μg /ml. The acidic and peroxide stressed study shows more degradation of 6.23% and 3.03%. Conclusion: The present developed method was found stability indicating, reliable, validated method was applied for the routine analysis of lercanidipine in bulk drug and the pharmaceutical formulations.

scholarly journals Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Haloperidol and Trihexyphenidyl in API and Combined Tablet Dosage Form

2018 ◽  
Vol 3 (03) ◽  
pp. 36-40 ◽  
Author(s):  
E. Amulya ◽  
N. Naveen Kumar ◽  
CH. Mounika ◽  
V. Kowmudi ◽  
N. Supriya ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Trihexyphenidyl and Haloperidol, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Altima C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 225 nm. The retention time of the Trihexyphenidyl and Haloperidol was 2.102, 3.537±0.02min respectively. The method produce linear responses in the concentration range of 15-75ppm of Trihexyphenidyland 37.5-187.5ppm of Haloperidol. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of pharmaceutical formulations.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OFTRANDOLAPRIL AND VERAPAMIL IN COMBINED TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (05) ◽  
pp. 61-64
Author(s):  
A. L Rao ◽  
◽  
R. V Bhaskara
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A reverse phase high performance liquid chromatographic method was developed and validated asper ICH guidelines for estimation of trandolapril and verapamil in combined tablet dosage form. Theseparation was obtained using a mobile phase consisting of acetonitrile and phosphate buffer adjustingpH to 3.0 in the ratio of 70:30 v/v and using Waters C18 (250 x 4.6 mm, 5 mcm) column maintained atambient temperature. The flow rate was 1.2 mL min-1 and UV detection was monitored at 215 nm. Theretention time (min) and linearity range (mcg mL-1) for trandolapril and verapamil were (5.12, 2.70) and(20-60, 20-60), respectively. The method validation results are within the acceptance criteria for precision,accuracy and linearity. The proposed method was found to be suitable for routine quality control ofmarketed formulation containing these APIs.

scholarly journals An Effective Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lamivudine and Raltegravir in Bulk and Their Tablet Dosage Form

2021 ◽  
pp. 263-277
Author(s):  
Gundapaneni Ravi Kumar ◽  
Rayala Rama Rao ◽  
Vadde Megha Vardhan ◽  
V. D. N. Kumr Abbaraju
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Effective Stability ◽  
Tablet Dosage

Background: In the current study, asimple and specific stability indicating RP-HPLC method was developed and validated for the determination of Lamivudine and Raltegravir in bulk drug and it tablet dosage form using an UV-detector. Good separation was achieved by isocratic ally on a Zorbax SB-Phenyl (150 × 4.6 mm, 3.5 μ, 80 A°) column, using a mobile phase composition of buffer (0.1% v/v Phosporic acid in water): Acetonitrile (40:60 v/v) at a flow rate of 1.0 mL/min. The eluted analytes detected at 260 nm wavelength. Results: Lamivudine and Raltegravir were eluted at 3.1 and 5.4 min respectively with run time 7 min. Linearity in the method was measured in the concentration range of 30 – 70 μg/mL and 60 – 140 μg/mL for Lamivudine and Raltegravirrespectively. The percentage recoveries of Lamivudine and Raltegravirwere determined to be 100.30% and 100.53%, respectively. The validation of the developed method is carried as per USFDA and ICH guidelines, and the degradants were well resolved from Raltegravir and Lamivudine peaks. The developed RP-HPLC method was highly precise, specific, sensitive, and stability indicating. Conclusion: The results of the analysis prove that thedeveloped RP-HPLC method is simple, economical and widely acceptable, which can be used in routine quality control tests in the industry.

scholarly journals Development of Stability Indicating, Validated Liquid Chromatographic Method for Estimation of Sarecycline in its Formulations

2019 ◽  
Vol 35 (6) ◽  
pp. 1805-1812
Author(s):  
Azmath Unissa ◽  
Anupama Koneru ◽  
M. Mushraff Ali Khan ◽  
Murali Balaram Varanasi ◽  
Imam Pasha Syed
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Stability Indicating ◽  
Stability Robustness ◽  
Technical Requirements ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A stability indicating HPLC method was developed and for the estimation of Sarecycline Hydrochloride in tablet dosage form using C18 column with a mobile phase composition of 0.1M Na2PO4 and Acetonitrile in the ratio of 50:50 v/v . The detection wave maxima and retention time were found to 242nm and 3.876min respectively. The method validation was carried out according to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and the parameters namely; precision, accuracy, specificity, stability, robustness, linearity, limit of quantitation (LOQ) and limit of detection (LOD) are evaluated. The present developed RP-HPLC method shows the purity angle of peaks is less than their threshold angle, signifying that it to be suitable for stability studies. Hence, the developed method can be used for the successful estimation of Sarecycline in the pharmaceutical dosage formulations.

scholarly journals Development and Validation of a Stability-Indicating HPTLC Method for Analysis of Rasagiline Mesylate in the Bulk Drug and Tablet Dosage Form

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Singaram Kathirvel ◽  
Suggala Venkata Satyanarayana ◽  
Garikapati Devalarao
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Linear Regression Analysis ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Rasagiline Mesylate ◽  
Development And Validation ◽  
Tablet Dosage

A simple and sensitive thin-layer chromatographic method has been established for analysis of rasagiline mesylate in pharmaceutical dosage form. Chromatography on silica gel 60 F254 plates with 6 : 1 : 2(v/v/v) butanol-methanol water as mobile phase furnished compact spots at Rf  0.76±0.01. Densitometric analysis was performed at 254 nm. To show the specificity of the method, rasagiline mesylate was subjected to acid, base, neutral hydrolysis, oxidation, photolysis, and thermal decomposition, and the peaks of degradation products were well resolved from that of the pure drug. Linear regression analysis revealed a good linear relationship between peak area and amount of rasagiline mesylate in the range of 100–350 ng/band. The minimum amount of rasagiline mesylate that could be authentically detected and quantified was 11.12 and 37.21 ng/band, respectively. The method was validated, in accordance with ICH guidelines for precision, accuracy, and robustness. Since the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.

scholarly journals Development of a Validated Stability Indicating Rp-Hplc Method for the Estimation of Pirfenidone in Bulk Drug and Tablet Dosage form

2021 ◽  
pp. 110-118
Author(s):  
C. Vanitha ◽  
Sravani Singirikonda
Keyword(s):  
Thermal Degradation ◽  
Dosage Form ◽  
Hplc Method ◽  
Forced Degradation ◽  
Column Temperature ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Tablet Dosage

Objective: The present work focused on developing a validated stability indicating RP-HPLC method for the estimation of pirfenidone in bulk drug and tablet dosage form. Methods: The chromatographic separation was performed on symmetry C18 (150 mm x 4.6, 5 micron) with a 1 ml/min flow rate at 315nm. The mobile phase employed was orthophosphoric acid buffer: acetonitrile (65:35). Column temperature was maintained at 30ºC. Pirfenidone was subjected to different forced degradation conditions according to ICH guidelines, including acid, base and neutral hydrolysis, oxidation, photolysis and thermal degradation.  Results: In alkali, acidic, oxidation and UV degradation conditions the drug shows considerable degradation. Pirfenidone was stable under neutral hydrolysis and thermal degradation. Pirfenidone was stable under extreme degradation conditions showing less than 8% of degradation in all degradation conditions. This result showed that pirfenidone was stable under stress degradation. Then the optimized method was validated for the parameters like linearity, accuracy, precision and robustness as per ICH guidelines.

Application of RP-HPLC Technique for development of Analytical method for Validation of Metformin hydrochloride from Bulk drug and Dosage form

2021 ◽  
pp. 265-268
Author(s):  
Rajan V. Rele ◽  
Sandip P. Patil
Keyword(s):  
Dosage Form ◽  
Metformin Hydrochloride ◽  
Reverse Phase ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
System Suitability ◽  
Liquid Chromatographic Method ◽  
Phase Liquid ◽  
Bulk Drug ◽  
Liquid Chromatographic

A Novel Reverse Phase Liquid Chromatographic Method was developed and validated for estimation of metformin hydrochloride in its dosage form i.e. tablets. The reverse phase HPLC analysis was carried out on isocratic system. The column was Hypersil BDS C18 (150mm x 4.6mm, 5µm) with ambient temperature. The mobile phase consisted of buffer: methanol in proportion 90:10 % (v/v). The flow rate was maintained at 1.0ml/ min. The detection was carried out at wavelength 230nm. The method was validated as per ICH guidelines for system suitability, linearity, accuracy and precision. The linear ranges were 50-150µg/ml for metformin hydrochloride, The accuracy and precision were found to be well within the acceptable limit. The method was successfully applied for determination Metformin hydrochloride in dosage form with good recoveries.

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