High-Performance Liquid Chromatographic Methods for the Determination of Ranitidine and Related Substances in Raw Materials and Tablets

Beaulieux, Normand; Lacroix, Pauline M.; Sears, R.W.; Lovering, Edward G

doi:10.1002/jps.2600771016

Cited by 24 publications

(8 citation statements)

References 4 publications

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“…Many analytical approaches are available for the related substances of ranitidine in tablet formulations and drug substances [1–3]. A number of assay methods for determination of ranitidine in pharmaceutical formulations and human plasma is also available [4–6].…”

Section: Introductionmentioning

confidence: 99%

A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form

Sharma

Rao²,

Kumar³

et al. 2011

Sci. Pharm.

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A selective, specific and stability-indicating gradient reverse phase high-performance liquid chromatographic (HPLC) method was developed for the determination of Ranitidine in presence of its impurities, forced degradation products and placebo substances such as saccharide and parabens. Ultraviolet detection was performed at 230 nm. Separate portions of the drug product and ingredients were exposed to stress conditions to induce oxidative, acidic, basic, hydrolytic, thermal and photolytic degradation. Ranitidine was found to degrade significantly at acidic, basic and oxidative stress conditions but was stable at heat and humidity. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. The method was validated over this range for (i) system suitability (ii) specificity, (iii) precision, (iv) limit of detection and limit of quantification, (v) linearity, (vi) accuracy, (vii) robustness. The method was found to be precise, accurate, linear and robust. The proposed method was successfully employed for estimation of Ranitidine impurities in pharmaceutical preparations.

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Section: Introductionmentioning

confidence: 99%

A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form

Sharma

Rao²,

Kumar³

et al. 2011

Sci. Pharm.

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“…Although HPLC methods with uv-dtection are routinely used for the determination of ranitidine [19][20][21][22][23][24][25] the procedures require maintenance of elevated column temperature 19 , lack of sensitivity 20,22,23 , involve multi extraction steps 21 and also several clean-up steps. They are time-consuming and often poorly reproducible.…”

Section: Discussionmentioning

confidence: 99%

“…HPLC [20][21][22][23][24][25][26] continues to occupy a prominent position among the methods used for the assay of ranitidine in pharmaceutical preparations. Several electroanalytical techniques including polarography 27,28 , differential pulse polarography 29 , oscillopolarography 30 , and linear sweep-voltammetry 31 have been employed for the sensitive determination of ranitidine in pharmaceuticals.…”

Section: Introductionmentioning

confidence: 99%

Untitled

Basavaiah¹,

Nagegowda²,

Ramakrishna³

2005

ScienceAsia

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Three simple, rapid, reliable and cost-effective methods based on titrimetry and spectrophotmetry in non-aqueous medium are described for the determination of ranitidine in pharmaceuticals. In titrimetry, the drug dissolved in glacial acetic acid was titrated with acetous perchloric acid with visual and potentiometric end point detection, crystal violet being used as indicator for visual titration. Spectrophotometry involved adding different amounts of the drug to a fixed amount of perchloric acid-crystal violet mixture followed by measurement of absorbance at 570 nm. The absorbance was found to increase linearly with the concentration of the drug and formed the basis for quantification. The titrimetric methods are applicable over 1-15 mg range of ranitidine, and in spectrophotometry, calibration graph was linear from 10 to 70 µg ml -1 . The apparent molar absorptivity is calculated to be 2.2 × 10 3 l mol -1 cm -1 and the calculated Sandell sensitivity is 161.7 ng cm -2 . The limits of detection and quantification are found to be 1.07 and 3.58 µg ml -1 , respectively. The procedures were used to determine ranitidine in pharmaceutical products and the results were found to be in good agreement with those obtained by the reference method. Associated pharmaceutical materials did not interfere. The accuracy and reliability of the methods were further ascertained by recovery studies via standard-addition technique with percent recoveries in the range 96.3 to 102.5 %.

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“…It is a H 2 -receptor antagonist and is widely used in short term treatment of duodenal ulcer and in the management of hypersecretory conditions [1]. Several techniques such as proton magnetic resonance spectroscopy [2], near infrared reflectance spectrometry [3], scintillation proximity assay [4], flow injection fluorimetry [5], polarography [6,7] polarography [8], capillary electrophoresis [9], liquid chromatography [10], and high performance liquid chromatography [11][12][13][14][15], have been used for the determination of RNH in pharmaceuticals. These techniques require sophisticated instruments and expensive reagents, and involve several manipulation steps and derivatization reactions.…”

Section: Introductionmentioning

confidence: 99%

Quantitation of ranitidine in pharmaceuticals by titrimetry and spectrophotometry using potassium dichromate as the oxidimetric reagent

Basavaiah

Somashekar

2007

JICS

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Four new methods are described for the determination of ranitidine hydrochloride (RNH) in bulk drug and in formulations employing titrimetric and spectrophotometric techniques and using potassium dichromate as the oxidimetric reagent. In titrimetry (method A), RNH is treated with a measured excess of dichromate in acid medium, and the unreacted oxidant is back titrated with iron(II) ammonium sulfate. The three spectrophotometric methods are also based on the oxidation of RNH by a known excess of dichromate under acidic conditions followed by the determination of surplus oxidant by three different reaction schemes. In one procedure (method B), the residual dichromate is treated with diphenylcarbazide and the absorbance measured at 540 nm. Calculated amount of iron(II) is added to residual dichromate and the resulting iron(III) is complexed with thiocyanate and measured at 470 nm (method C). Method D involves reduction of unreacted dichromate by a calculated amount of iron(II) and estimation of residual iron(II) as its orthophenanthroline complex after raising the pH, and measuring the absorbance at 510 nm. In all the methods, the amount of dichromate reacted corresponds to the drug content. The experimental conditions are optimized. The titrimetric procedure is applicable over 5-10 mg range. In spectrophotometric methods, Beer's law is obeyed in the ranges 5-50, 5-80, and 10-100 μg ml -1 for method B, method C, and method D, respectively. The methods were validated for accuracy, precision and recovery. The proposed methods were applied to the analysis of RNH in the tablet and the injection forms, and the results were in agreement with those obtained by the reference method.

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High-Performance Liquid Chromatographic Methods for the Determination of Ranitidine and Related Substances in Raw Materials and Tablets

Cited by 24 publications

References 4 publications

A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form

A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form

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Quantitation of ranitidine in pharmaceuticals by titrimetry and spectrophotometry using potassium dichromate as the oxidimetric reagent

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