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DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DROTAVERINE HYDROCHLORIDE AND PARACETAMOL IN TABLET DOSAGE FORM

S Suresh Kumar, B Kalyan Kumar

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Abstract

A simple, precise, rapid and economic reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of drotaverine hydrochloride (DROTA) and paracetamol (PARA) in a tablet formulation. Chromatography was carried out at ambient temperature on a Hypersil (BDS) C 18 (150mm x 4.6 mm), 5 µm column with the isocratic mode. The mobile phase consisting of Acetate Buffer P H 3: Acetonitrile (45:55% v/v) at a flow rate of 1 ml/min. The UV detection was carried out at 230 nm. DROTA and PARA were separated in less than 10 min. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines.

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What this paper is about

A simple, precise, rapid and economic reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of drotaverine hydrochloride (DROTA) and paracetamol (PARA) in a tablet formulation. Chromatography was carried out at ambient temperature on a Hypersil (BDS) C 18 (150mm x 4.6 mm), 5 µm column with the isocratic mode. The mobile phase consisting of Acetate Buffer P H 3: Acetonitrile (45:55% v/v) at a flow rate of 1 ml/min. The UV detection was carried out at 230 nm. DROTA and PARA were separated in less than 10 min. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines.

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Available abstract

A simple, precise, rapid and economic reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of drotaverine hydrochloride (DROTA) and paracetamol (PARA) in a tablet formulation. Chromatography was carried out at ambient temperature on a Hypersil (BDS) C 18 (150mm x 4.6 mm), 5 µm column with the isocratic mode. The mobile phase consisting of Acetate Buffer P H 3: Acetonitrile (45:55% v/v) at a flow rate of 1 ml/min. The UV detection was carried out at 230 nm. DROTA and PARA were separated in less than 10 min. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines.

Key concepts: Chromatography, Acetonitrile, Dosage form, Chemistry, High-performance liquid chromatography

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DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DROTAVERINE HYDROCHLORIDE AND PARACETAMOL IN TABLET DOSAGE FORM — Research Paper | ScholarLens