Development and validation of an RP-HPLC method for simultaneous analysis of drotaverine and omeprazole in a tablet dosage form

Panigrahi, Debadash; Sharma, Rajesh

doi:10.1556/achrom.20.2008.3.10

Cited by 6 publications

(3 citation statements)

References 14 publications

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“…The chromatographic separation of drotaverine and omeprazole was achieved on a C 18 column with methanol and 0.1 m ammonium acetate pH 5, adjusted with orthophosphoric acid as the mobile phase in a ratio of 60:40 v/v. Drotaverine (log P 5.35) is ionized at acidic pH and the methanol in the mobile phase causes solvation of the ionized analyte drotaverine and is retained more in the column than the less nonpolar analyte omeprazole (log P 2.23 Panigrahi & Sharma, 2008).…”

Section: Influence Of Organic Modifier On Retentionmentioning

confidence: 99%

Retention behaviour of analytes in reversed‐phase high‐performance liquid chromatography—A review

V.¹,

Basuri²,

Sahini³

et al. 2022

Biomedical Chromatography

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The understanding of principles that drive the separation in reversed‐phase chromatography plays an important role in the prediction of the elution of solutes in RP‐HPLC. The separation in RP‐HPLC is based on the principle of adsorption and partition. In addition, the logP value, the pKa value of the drug and chromatographic parameters like mobile phase pH, buffer concentration, organic modifier and mobile phase additives also influence the retention and selectivity of the analyte. It was found that hydrophobic, electrostatic, hydrogen bonding and other specific interactions between the stationary phase and the solutes, along with the hydrophobicity of an analyte molecule (logP), modify the retention behaviour of the analytes. This article gives special attention to the influence of ionization and ion interaction on the separation of analytes. The drug molecules with different logP values containing protonated and deprotonated acids, bases and zwitterions are selected as examples and this article addresses various issues related to the method development, relationships between analyte retention and mobile phase pH and the pKa value of the analyte. The advances in this regard, with highlights on topics such as mechanisms of retention and various factors that influence the retention behaviour of analytes, are also updated with suitable examples.

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Section: Influence Of Organic Modifier On Retentionmentioning

confidence: 99%

Retention behaviour of analytes in reversed‐phase high‐performance liquid chromatography—A review

V.¹,

Basuri²,

Sahini³

et al. 2022

Biomedical Chromatography

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“…It is a NSAID; used in the management of osteoarthritis; rheumatoid arthritis; and ankylosing spondylitis [3] . A few UV spectrophotometric andHPLC [4][5][6][7] methods have been reported individually or in combination with other drugs for estimation of DRH. The aim of present study wasto propose a simple and sensitive method for quantification of DRHand AF to validate the procedures in order to demonstrate its good analytical and statistical parameters.…”

Section: Introductionmentioning

confidence: 99%

Simple and Sensitive Method for the Simultaneous Estimation of Drotaverine HCL and Aceclofenac Using RP-HPLC

Muralidharan¹,

Internationals²

2014

JPP

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To develop a simple and sensitive method for the simultaneous estimation of drotaverine HCL (DRH) and aceclofenac (AF) using RP-HPLC. The HPLC separation was achieved on a thermo column (250 mm × 4.6 mm, 5μ) with an isocratic mixture of acetonitrile and 5 mM of ammonium acetate in the ratio of 65:35, pH adjusted to 4.5 at a flow rate of 1.0 ml/min and the detection at 285nm. The method was validated as per ICH guidelines. The retention time for DRH and AF was 3.9 and 5.0 minutes, respectively. The optimized method was linear in the range of 50-120 ng/ml and 100-700 ng/ml for DRH and AF respectively. The overall recovery of DRH and AF were 99.8 and 99.5 % respectively. The developed sensitive, robust and rugged method as proven reproducibility of the result obtained as an outcome of small deliberate variation in the analytical parameter and the change the operator.

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“…A detailed literature survey revealed that there are some analytical methods reported for the estimation of drotaverine either individually or in combination with other drugs like HPTLC [ 8 ], spectrophotometric [ 9 – 14 ], by derivative spectrophotometry [ 15 ], and by HPLC [ 16 – 32 ]. The route of synthesis of drotaverine and possible degradants resulted in four known impurities, Impurity 1, Impurity 2, Impurity 3, and Impurity 4, which are not reported in any of the pharmacopeia.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Stability-Indicating RP-HPLC Method for the Estimation of Drotaverine Impurities in API and Pharmaceutical Formulation

et al. 2014

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A sensitive, stability-indicating gradient RP-HPLC method with PDA detection has been developed for the simultaneous analysis of drotaverine impurities in active pharmaceutical ingredient (API) and pharmaceutical formulations. Efficient chromatographic separation was achieved on an XTerra RP18, 150 × 4.6 mm, 5 μm column using gradient elution at 230 nm detection wavelength. The optimized mobile phase consisted of a 0.02 M potassium dihydrogen orthophosphate buffer of pH 3.0 as solvent A and acetonitrile as solvent B. The flow rate of the mobile phase was 1.0 mL min−1 with a column temperature of 25°C. The method showed linearity over the range of 0.251–10.033 μg/mL, 0.231–9.995 μg/mL, 0.230–10.089 μg/mL, 0.334–10.011 μg/mL, and 0.324–10.050 μg/mL for impurities 1, 2, 3, 4, and drotaverine, respectively, with a correlation coefficient greater than 0.999. The relative retention times and relative response factors of impurities 1, 2, 3, 4 were 0.36, 0.90, 1.42, 1.55 and 1.04, 0.84, 1.10, 1.30, respectively. The drotaverine formulation sample was subjected to the stress conditions of acid, base, oxidative, thermal, humidity, and photolytic degradation. Drotaverine was found to degrade significantly in peroxide, base, and heat stress conditions. The degradation products were well-resolved from drotaverine and its impurities. The peak purity test results confirmed that the drotaverine peak was homogenous and pure in all stress samples and the mass balance was found to be more than 98%, thus proving the stability-indicating power of the method. The developed method was validated according to ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness.

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Development and validation of an RP-HPLC method for simultaneous analysis of drotaverine and omeprazole in a tablet dosage form

Cited by 6 publications

References 14 publications

Retention behaviour of analytes in reversed‐phase high‐performance liquid chromatography—A review

Retention behaviour of analytes in reversed‐phase high‐performance liquid chromatography—A review

Simple and Sensitive Method for the Simultaneous Estimation of Drotaverine HCL and Aceclofenac Using RP-HPLC

Development and Validation of a Stability-Indicating RP-HPLC Method for the Estimation of Drotaverine Impurities in API and Pharmaceutical Formulation

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