HPTLC Method For Estimation Research Articles

Development and Validation of an HPTLC Method for Estimation of Berberine in Berberis aristata

Development and Validation of an HPTLC Method for Estimation of Berberine in Berberis aristata

Development of HPTLC Method for Estimation of Gallic Acid and Bergenin in Actaea acuminata Roots

Development of HPTLC Method for Estimation of Gallic Acid and Bergenin in Actaea acuminata Roots

Development and validatation of HPTLC method for estimation of irbesartan in bulk and tablet dosage form

A simple, rapid and accurate High performance thin layer chromatography is described for the Development and validation of HPTLC method for Irbesartan in bulk and Pharmaceutical dosage form. The separation is carried out on Merck TLC aluminum sheets of silica gel 60 F254 using Ethyl acetate: Chloroform (6.5:3.5v/v) mobile phase. Quantification was done by Densitometric scanning at 254nm. The linearity was found to be the range of 100-500ng/spot for Irbesartan with the correlation coefficient of 0.9992. The regression equation was found to be Y=7.2733x+703.15. The Rf value of Irbesartan was found to be 0.55. The LOD and LOQ were found to 8.24 and 24.74 respectively. Average recovery was found to be 99.66% which show that the method was free from interference from excipients present in the formulation. Simultaneously the Percentage relative standard deviation was well within the range of 2%. The above method was validated according to the ICH guidelines. The established method enabled accurate, precise and applied to the analysis of Irbesartan in bulk and Pharmaceutical dosage form. Â

Development and Validation of Stability Indicating HPTLC Method for Estimation of Felodipine and Its Application to Degradation Kinetic Study of Felodipine in Alkaline Medium

Development and Validation of Stability Indicating HPTLC Method for Estimation of Felodipine and Its Application to Degradation Kinetic Study of Felodipine in Alkaline Medium

Development and validation of HPTLC method for estimation of Tribulosin; an important biomarker in Indian Tribulus terrestris

Development and validation of HPTLC method for estimation of Tribulosin; an important biomarker in Indian Tribulus terrestris

Development of stability indicating HPTLC method for estimation of antihypertensive drug combination nifedipine and valsartan

ABSTRACTA precise and accurate method for the analysis of antihypertensive drug combination nifedipine and valsartan was developed using the HPTLC method. The stationary phase used was a pre-coated silica gel G60 – F254 aluminium sheet and the mobile phase was acetonitrile: methanol: n-butanol: acetic acid (6:2:2:0.1, v/v/v/v). The detection of spots was carried out densitometrically using a UV detector at 230 nm in the absorbance mode. The Rf values of valsartan and nifedipine were found to be 0.25 and 0.65, respectively. The calibration curve was found to be linear in the range of 120–320 ng/band and 900–2400 ng/band for nifedipine and valsartan, respectively. Forced degradation studies were performed using stress conditions like acid and base hydrolysis, photolytic, thermal and oxidative stress degradation to develop the stability indicating method. The degradation study indicated that nifedipine was susceptible to acid-base hydrolysis, oxidative stress degradation and photolytic degradation, while valsartan was susceptible to acid-base hydrolysis and oxidative stress degradation.

Development and Validation of Stability Indicating HPTLC Method for Estimation of Salmeterol Xinafoate

A simple, rapid validated stability indicating HPTLC method for estimation of Salmeterol xinafoate was successfully developed. This method is based on HPTLC separation followed by UV detection at 252 nm. The separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 using Chloroform: Methanol: Ammonia (7:3:0.5 v/v/v) as a mobile phase and scanning was done by using TLC Scanner III. Salmeterol xinafoate gave well defined and sharp peak at Rf 0.52 ± 0.05 at 252 nm. Calibration curve was linear in range 1000-3000 ng/band for Salmeterol xinafoate. Stress degradation study includes hydrolysis under different pH, oxidation, thermal and photolytic conditions. The suitability of this HPTLC method for quantitative estimation of Salmeterol xinafoate was proved by validation in accordance with requirements of ICH guidelines Q2A (R1).

Development and Validation of Stability Indicating HPTLC Method for Estimation of Acebrophylline in Their Dosage Form

Development and Validation of Stability Indicating HPTLC Method for Estimation of Acebrophylline in Their Dosage Form

Stability-Indicating HPTLC Method for Estimation of Benazepril in Bulk and Tablet Dosage Form

A stability-indicating high-performance thin-layer chromatography method for determination of benazepril both in bulk and pharmaceutical formulation has been developed and validated as per ICH guidelines. The benazepril was analyzed on pre-coated silica gel GF254 plates using Carbon tetrachloride: Methanol: Triethylamine (7.6: 2.4: 0.1 v/v) as the mobile phase. The concentration of benazepril was determined by densitometry at 240 nm. The method was found to be linear, with r2 = 0.998±0.3347 in the concentration range 200 - 1200 ng per spot. The LOD and LOQ were 19.48 ng and 59.03 ng per spot respectively. Benazepril was subjected to forced degradation like acid and alkali hydrolysis, oxidation, photo and thermal degradation. The drug was found to degrade under acidic, basic, oxidative and thermal conditions. The degraded product was well resolved from the pure drug with significantly different Rf value. In validation, it was found that the method is repeatable, selective and accurate for the estimation of benazepril. The proposed developed stability-indicating HPTLC method can be applied for identification and quantitative determination of benazepril in bulk drug and pharmaceutical formulation.

STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF CLEVIDIPINE BUTYRATE IN SYNTHETIC MIXTURE

Objective: To develop and validate stability indicating HPTLC method for determination of clevidipine butyrate in synthetic mixture.Methods: The present study deals with development and validation of stability indicating HPTLC method for estimation of clevidipine butryate. Chromatographic separation was performed on aluminum plate pre coated with Silica Gel 60 F254 using toluene: ethyl acetate (8:2) as mobile phase. TLC scanner was set at wavelength of 370 nm.Results: Retention factor Rf of clevidipine was found to be 0.49. The method was validated as per ICH guidelines. Calibration curve was in the range of 1000-6000ng/band. The correlation coefficient was found to be 0.999. The precision expressed by RSD was less than 2%. The accuracy of method was confirmed by recovery studies using standard addition method and recovery was found to be 99.03-99.57%. The drug was subjected to ICH prescribed hydrolytic, oxidative, photolytic and thermal stress conditions. Clevidipine and its degradation products were well resolved under experimental conditions. The method was validated according to ICH guidelines. The drug showed significant degradation in alkaline and acidic condition and slight degradation in oxidative condition. The drug was stable in thermal condition.Conclusion: A new, Simple, Accurate, Precise, Sensitive and economic stability indicating HPTLC method has been developed and validated for the determination of clevidipine and can be employed for stability indicating analysis.

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF ELLAGIC ACID IN ANTIDIABETIC HERBAL FORMULATION

A simple, sensitive, precise, rapid and reliable HPTLC method for the estimation of ellagic acid in marketed herbal formulation, Glucomap tablet was developed. In this method, precoated Silica Gel F254 Plates were used as stationary phase and Toluene: ethyle acetate: formic acid: methanol (3:3:8:2 v/v) as mobile phase. Developed chromatogram was scanned at 280 nm, the wavelength of maximum absorption for ellagic acid. The aptness of developed HPTLC method for estimation of ellagic acid was established by validating it as per the ICH guidelines. The content of ellagic acid in crude drug Terminalia arjuna and polyherbal formulation was also studied. The developed method has been successfully applied for the determination of ellagic acid in polyherbal formulation.

A Validated Stability Indicating HPTLC Method for Estimation of Mycophenolate Sodium

A Validated Stability Indicating HPTLC Method for Estimation of Mycophenolate Sodium

Development and validation of stability indicating HPTLC method for estimation of dextromethorphan hydrobromide

A simple, sensitive and accurate stability indicating HPTLC method has been developed and validated for estimation of Dextromethorphan hydrobromide in bulk and pharmaceutical dosage form. The drug was spotted on precoated silica gel 60 F254 aluminum plates using Toluene: Methanol: Triethylamine (8.5:1:0.5 v/v/v) as mobile phase. The retention factor (Rf) was found to be 0.60±1.92. The detection of band was carried at 225 nm. The drug was subjected to different stress conditions like acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the concentration range of 2000-20000 ng/band with correlation coefficient 0.991. The method found to be accurate as results of the recovery studies are close to 100 %. The developed method was found to be simple, sensitive, selective, accurate and repeatable for analysis of and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form.

Development and Validation of Stability-Indicating HPTLC Method for Estimation of Naratriptan Hydrochloride in Its Pharmaceutical Dosage Form and Its Content Uniformity Testing.

The present research project involves development and validation of a stability-indicating HPTLC method for the estimation of naratriptan-HCl in their pharmaceutical dosage forms and its content uniformity testing. Naratriptan-HCl was subjected to alkaline, acidic, oxidative, neutral, thermal (dry heat) and photo-degradation conditions. The chromatographic separation was carried out using a precoated silica gel G 60 F254 TLC plate as the stationary phase and dichloromethane-toluene-methanol-triethylamine (4 : 4 : 2 : 1, v/v/v/v) as the mobile phase. The spots of NRT-HCl and its degradation products were detected at 290 nm. The Rf value of NRT-HCl was found to be 0.60 ± 0.02. The linearity was obtained in the range of 100-500 ng/spot. The limit of detection and limit of quantitation were found to be 6.07 ng/spot and 18.41 ng/spot, respectively. The percentage recovery was found in the range of 98.87-99.55%. NRT-HCl was degraded under acidic, alkaline and oxidative conditions while stable under photolytic, neutral and dry heat conditions. The developed method was applied for estimation of naratriptan-HCl in marketed formulations and its content uniformity testing.

Stability-Indicating HPTLC Method for Estimation of Guaifenesin in Bulk and in Pharmaceutical Formulation

A HPTLC/ Densitometric method has been developed for the determination of Guaifenesin (GFN) in bulk and pharmaceutical formulation. The estimation of drug was performed on HPTLC aluminium plates precoated with silica gel 60 RP-18 TLC F254 S using toluene: methanol: ethyl acetate: acetic acid (7:0.8:1.2:0.5 v/v/v/v) as mobile phase. The densitometric quantification for the drug was carried out at 274 nm. GFN obeyed linearity in concentration range 800 – 2800 ng/band with coefficient of correlation 0.999. The Rf for GFN was found to be 0.6 ± 0.02. The proposed method was applied for pharmaceutical formulation and % label claim for GFN was found to be 100.34 ± 1.06. The method was validated for accuracy, precision and ruggedness. Accuracy of the method was checked by recovery studies at three different levels i.e. 80 %, 100 % and 120 %. The % recovery of GFN was found to be in the range of 99.48% - 100.68 %; the % RSD value was less than 2 indicates the accuracy of the method. The method was found to be precise as indicated by the inter-day, intra-day and repeatability analysis; showing % RSD less than 2. The results did not show any statistical difference between operators showing that developed method was rugged. GFN was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acid-base conditions, hydrolysis, oxidation, photo degradation except dry heat degradation. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved from the pure drug with significantly different Rf value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for the identification and quantitative determination of GFN in bulk drug and pharmaceutical formulation.

A Validated Stability Indicating HPTLC Method for Estimation of Ribavirin in Capsule in Presence of its Alkaline Hydrolysis Degradation Product

A sensitive stability indicating HPTLC method was developed and validated for quantitative determination of Ribavirin in capsule. Chromatographic separation was performed on precoated silica gel 60F254 HPTLC plates using Chloroform: Methanol: Water (6.0:3.5:.0.5 v/v/v) as a mobile phase. A TLC scanner set at 254 nm was used for direct evaluation of the chromatograms in reflectance/absorbance mode. Ribavirin and degradant were satisfactorily resolved with Rf values of 0.52 ± 0.05, 0.20 ± 0.05 respectively. Calibration curve was linear in the concentration range of 100-600 ng/band. The high correlation coefficient (r2>0.9994) values indicated clear correlations between the investigated compound concentrations. Method was validated according to ICH guidelines. The repeatability and intermediate precision, expressed by the RSD, were less than 2.0 %. The accuracy and validity of the method were further determined by performing recovery studies via a standard addition method. The accuracy of the method expressed as percent recovery was satisfactory (99.86 %). The drug was subjected to the International Conference on Harmonization (ICH)-prescribed oxidative, hydrolytic, thermal stress and photolytic conditions. The drug showed instability in alkaline while it remained stable in acid, heat and UV radiation conditions. The proposed HPTLC method was utilized to investigate of alkaline degradation of Ribavirin. The performance of the method was validated according to the present ICH guidelines for accuracy, precision, specificity, and limit of detection, limit of quantification, linearity, ruggedness and robustness.

Development and Validation of HPTLC Method for Estimation of Propranolol Hydrochloride and Flunarizine Dihydrochloride in Combined Dosage Form

A simple, sensitive, and precise high-performance thin layer chromatographic method has been developed for the estimation of propranolol hydrochloride and Flunarizine dihydrochloride in combined dosage form. The method employed HPTLC aluminum plates precoated with silica gel 60F as the stationary phase while the solvent system was toluene:methanol: ethyl acetate: acetic acid (7 : 1.5 : 1.5 : 0.1 v/v/v/v). The Rf value was observed to be 0.07±0.02 and 0.67±0.02 for propranolol hydrochloride and flunarizine dihydrochloride. The densitometric analysis was carried out in absorbance mode at 240 nm. The method was linear in the range of 400–2400 ng/band for propranolol hydrochloride and 50–300 ng/band for flunarizine dihydrochloride. The method was validated with respected accuracy, precision and specificity. The limit of detection for Propranolol hydrochloride and flunarizine dihydrochloride were found to be 118.4 and 13.75 ng/spot, respectively. The limit of quantification for propranolol hydrochloride and flunarizine dihydrochloride was found to be 355.2 and 45.4 ng/band, respectively. The method was successfully applied to the estimation of propranolol hydrochloride and flunarizine dihydrochloride in combined dosage form.