Development and Validation of Stability Indicating Assay Method for Determination of Felodipine in Tablet Dosage Form

A simple and sensitive, HPTLC method has been developed for the quantitative estimation of felodipine in it’s single component tablet formulation. The separation was carried out on Merck aluminium plates precoated with silica Gel 60 F254 using n -hexane: ethyl acetate in the ratio of 6:4 (v/v) as mobile phase. Felodipine showed Rf value of 0.53 ± 0.027 and was scanned at 366 nm using Camag TLC Scanner 3. The linear regression data for the calibration plot showed a good relationship with r=0.9792. The method was validated for precision and recovery. The limits of detection and quantification were 23.54 and 71.33 ng/spot respectively. The developed method was successfully used for the assay of felodipine tablet formulations. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.

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Validated TLC-densitometry method for determination of cetirizine dihydrochloride in tablet dosage form

International Current Pharmaceutical Journal ◽

10.3329/icpj.v3i1.17294 ◽

2013 ◽

Vol 3 (1) ◽

pp. 208-210

Author(s):

Nia Kristiningrum ◽

Ellsy Novita Martyanti

Keyword(s):

Mobile Phase ◽

Limit Of Detection ◽

Pharmaceutical Journal ◽

Limit Of Quantification ◽

Quality Control Testing ◽

Relative Standard ◽

Tablet Formulations ◽

Tablet Dosage ◽

Chloroform Methanol

A rapid, reproducible and accurate TLC method was developed for the determination of Cetirizine Dihydrochloride in tablet. The analytes were dissolved with ethanol 70% and chromatographed on silica Gel GF 254 TLC plate using chloroform : methanol : ethyl acetate in the ratio of 2 : 7 : 3 (v/v) as mobile phase. Quantitative analysis was done through densitometric measurement at wavelength 234 nm. Method was found linear over the concentration range of 400 1600 ng/spot with the correlation coefficient of 0.996. Specificity showed calculation of purity and identity more than 0.99. The limit of detection (LOD) and the limit of quantification (LOQ) of the method were 75.54 and 226.64 ng/spot. The relative standard deviation of this method was 0.86% whereas the means of the recovery data was 100.54 ± 0.11%. The proposed method has been applied to the determination of Cetirizine Dihydrochloride in commercial tablet formulations and the result were 96.97 ± 0.86 % for brand A and 100.57 ± 1.17 % for brand B. The developed method was successfully used for the assay of Cetirizine Dihydrochloride. This method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.DOI: http://dx.doi.org/10.3329/icpj.v3i1.17294 International Current Pharmaceutical Journal, December 2013, 3(1): 208-210

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Development and Validation of Stability Indicating HPTLC Method for Determination of Diacerein and Aceclofenac as Bulk Drug and in Tablet Dosage Form

E-Journal of Chemistry ◽

10.1155/2012/719264 ◽

2012 ◽

Vol 9 (4) ◽

pp. 2023-2028 ◽

Cited By ~ 4

Author(s):

S. P. Gandhi ◽

M. G. Dewani ◽

T. C. Borole ◽

M. C. Damle

Keyword(s):

Assay Method ◽

Stability Indicating ◽

Dry Heat ◽

Wet Heat ◽

Anti Inflammatory ◽

Bulk Drug ◽

Development And Validation ◽

Tablet Dosage ◽

Hptlc Method

Diacerein is a drug for osteoarthritis and is di-acetylated derivative of rein. Aceclofenac is used as an effective non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic properties. The present study describes degradation of diacerein and aceclofenac under ICH prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat, and photolysis) and establishment of a stability-indicating HPTLC assay method. Different degradation peaks were observed for diacerein when it was exposed to alkaline, and acid catalysed hydrolysis. For aceclofenac, decrease in peak area was observed with single peak of degradation product after oxidation. For HPTLC, RP-18 F254spre-coated plates, and mobile phase consisting of methanol: water 7: 3 v/v was used to achieve separation. Quantitation was done at 268 nm. The method was validated as per ICH Q2 R1 guidelines and results were in limit. The method was found to be simple, specific, precise, and stability indicating.

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A VALIDATED METHOD FOR THE DETERMINATION OF TAPENTADOL HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL FORMULATION BY DENSITOMETRIC ANALYSIS

INDIAN DRUGS ◽

10.53879/id.49.12.p0051 ◽

2012 ◽

Vol 49 (12) ◽

pp. 51-55

Author(s):

S Kathirvel ◽

◽

K. Madhu Babu

Keyword(s):

Mobile Phase ◽

High Performance ◽

Dosage Form ◽

Chromatographic Method ◽

Glacial Acetic Acid ◽

Calibration Plot ◽

Pharmaceutical Dosage Form ◽

Aluminum Plates ◽

Tablet Dosage

Described in this manuscript is the first reported new, simple high performance thin layer chromatographic method for the determination of tapentadol hydrochloride in bulk and its tablet dosage form. The drug was separated on aluminum plates precoated with silica gel 60 F254 with butanol: water: glacial acetic acid in the ratio of 6:2:2 (v/v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 254 nm. The method was validated for linearity, accuracy, precision and robustness. The calibration plot was linear over the range of 200-600 ng band -1 for tapentadol hydrochloride. The method was successfully applied to the analysis of drug in a pharmaceutical dosage form.

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RP-HPLC AND HPTLC STABILITY INDICATING ASSAY METHODS FOR IVERMECTIN IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.55.03.11143 ◽

2018 ◽

Vol 55 (03) ◽

pp. 32-42

Author(s):

G. P Wani ◽

◽

S. B Jadhav

Keyword(s):

Mobile Phase ◽

Stress Testing ◽

Hplc Method ◽

Rp Hplc ◽

Assay Methods ◽

Photo Stability ◽

Tablet Dosage ◽

Hptlc Method ◽

Alkaline Oxidation

Simple, rapid, precise, accurate RP-HPLC and HPTLC methods have been developed and validated for ivermectin in bulk and its marketed formulation. RP-HPLC method for drug was achieved on Grace C18 (250 mm X 4.6 ID, Particle size; 5 μ) column using mobile phase acetonitrile: 10 mM phosphate buffer (95:05 v/v) pH adjusted to 3 with o-phosphoric acid. Detection of drug was done at 245 nm. The retention time was found to be 5.83 min. HPTLC method for ivermectin was accomplished on a precoated silica gel aluminium plate 60F-254 (CAMAG Linomat 5), using toluene: methanol: glacial acetic acid (8:2:0.1 v/v/v) as a mobile phase. The densitometric scanning was performed at 245 nm which showed Rf 0.46 for ivermectin. The stress testing of the drug individually was carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions. The proposed methods were successfully applied for the determination of drug in bulk and its marketed formulation.

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Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2019.v12i7.33938 ◽

2019 ◽

pp. 275-279

Author(s):

VAIBHAV S KHODKE ◽

GAME MD

Keyword(s):

Spectrophotometric Method ◽

Dosage Form ◽

Quantitative Estimation ◽

Spectroscopic Method ◽

Quality Criteria ◽

Pharmaceutical Dosage Form ◽

Development And Validation ◽

Tablet Dosage ◽

Good Agreement

Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency. Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm. Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims. Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.

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Development and validation of stability indicating assay method for estimation of lumefantrine in bulk and tablet dosage form

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v11ispl4.4398 ◽

2020 ◽

Vol 11 (SPL4) ◽

pp. 1921-1927

Author(s):

Vijay H Ikale ◽

Hemant K. Jain ◽

Ashish B. Budhrani ◽

Manoj S. Patil ◽

Tikesh Agrawal ◽

...

Keyword(s):

Chromatographic Analysis ◽

Mobile Phase ◽

Assay Method ◽

Oxidation Condition ◽

Stability Indicating ◽

Stability Indicating Method ◽

Degradation Studies ◽

Development And Validation ◽

Neutral Conditions ◽

Tablet Dosage

Simple, precise, accurate, sensitive, economical, and rapid stability indicating method was developed for the estimation of Lumefantrine in bulk and tablets. Chromatographic analysis was performed on A Hibar C18 (4.6×250 mm, 5μm) column and mobile phase made up of acetonitrile: methanol (50:50 v/v); used for this study. The flow rate of the mobile phase was to 1.2 ml/min; the temperature of the column was adjusted to 40°C and UV analysis was carried out at 234 nm. The degradation studies were performed and the analytical method was validated as per ICH Q2R1 guideline. The Retention time of Lumefantrine was found to be 8.8 min. The developed method was found to be linear in the concentration range of 10-60 μg/ml. The value of the correlation coefficient between peak area and concentration was found to be 0.995. The value of % RSD was found to be within prescribed limits for precision studies which indicate reproducibility of the method. The values of LOD and LOQ were obtained at 14.54 and 44.07 μg/ml, respectively. The results of degradation studies indicate that the drug was found to be stable in acidic, basic, neutral, photolytic, and neutral conditions while degraded in oxidation condition.

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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PERINDOPRIL ERBUMINE AND AMLODIPINE BESYLATE IN BULK AND TABLET DOSAGE FORM BY HPLC

INDIAN DRUGS ◽

10.53879/id.50.05.p0032 ◽

2013 ◽

Vol 50 (05) ◽

pp. 32-35

Author(s):

S. R Pattan ◽

◽

A.C Patni ◽

R.A Mali ◽

C.J. Patni ◽

...

Keyword(s):

Analytical Method ◽

Mobile Phase ◽

Method Development ◽

Amlodipine Besylate ◽

Perindopril Erbumine ◽

Relative Standard ◽

Method Development And Validation ◽

Development And Validation ◽

Tablet Dosage

The objective of this present work was to develop and validate analytical method for quantitative determination of perindopril erbumine and amlodipine besylate in bulk as well as in tablet formulation. The chromatographic separation of the two drugs was achieved on a Varian Microsorb-MV 100-5 C18 column (150×4.6mm, 10 μm). The mobile phase constituted of acetonitrile: buffer (65:35) and pH adjusted to 2.6 with ortho- phosphoric Acid was delivered at the flow rate 1mL/min. Detection was performed at 210 nm. Separation was completed within 6 min calibration curves were linear with correlation coefficient between 0.99 to 1.0 over the concentration range of 2.5 to 15 µg/mL of perindopril erbumine and 10 to 60 µg/mL of amlodipine besylate The relative standard deviation (R.S.D.) was found <2.3%. The proposed method is precise, accurate, selective and rapid for the simultaneous determination of perindopril erbumine and amlodipine besylate.

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VALIDATED HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF OLMESARTAN MEDOXIMIL AND METOPROLOL SUCCINATE IN TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.49.10.p0013 ◽

2012 ◽

Vol 49 (10) ◽

pp. 13-17

Author(s):

V. V Kunjir ◽

◽

S. B. Jadhav ◽

A. J Purkar ◽

P. D. Chaudhari

Keyword(s):

Simultaneous Determination ◽

Mobile Phase ◽

High Performance ◽

Dosage Form ◽

Chromatographic Method ◽

Metoprolol Succinate ◽

Ich Guidelines ◽

Tablet Dosage ◽

Hptlc Method

A high performance thin layer chromatographic method has been developed for the simultaneous determination of olmesartan medoximil and metoprolol succinate from tablet dosage form. The mobile phase consisting of water-methanol-ammonium sulphate (4.5:4.5:1.5 v/v/v) and wavelength of detection 233 nm was used. The developed method was validated as per ICH guidelines.

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DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR QUANTITATIVE ESTIMATION OF PALIPERIDONE

INDIAN DRUGS ◽

10.53879/id.55.09.10939 ◽

2018 ◽

Vol 55 (09) ◽

pp. 34-40

Author(s):

A Shirode ◽

◽

C. Garade ◽

V. Kadam

Keyword(s):

Mobile Phase ◽

Quantitative Estimation ◽

Water Soluble ◽

Uv Detector ◽

Analytical Method Validation ◽

Starting Position ◽

Ich Guidelines ◽

Sample Application ◽

Development And Validation ◽

Hptlc Method

A planar chromatography (HPTLC) method has been developed and validated for quantitative estimation of the atypical antipsychotic drug paliperidone, which is weakly basic and poorly water soluble. The Camag HPTLC system, operated by software winCATS (ver.1.4.1.8), was used. Sample application was facilitated by Linomat 5 applicator. After sample application, plates were subjected to ascending development in twin trough chamber of size 10 cm x10 cm, using about 10 mL of mobile phase. The optimized mobile phase was composed of ethyl acetate:chloroform:toulene:methanol (2.5:2.5:2.5:2.5 v/v/v/v). In post development, the plates were air dried and then scanned densitometrically using a UV detector at 278 nm in absorbance mode. In HPTLC densitogram, well defined peak was obtained for paliperidone with starting position at 0.27 Rf, max position at 0.31 Rf and end position at 0.34 Rf. The optimal Rf value for paliperidone was found to be 0.31. Performance characteristics of proposed and newly developed HPTLC method were statistically validated as per recommendations of ICH guidelines of analytical method validation. The HPTLC method was found to be linear across the range from 20 to 140 ng/band. The LOD and LOQ values were found to be 1.288 and 3.905ng/band, respectively. The method was found to be accurate, precise, robust and economical for the determination of paliperidone from bulk and its extended release tablet formulation.

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