Asian Journal of Pharmaceutical Analysis

Govinda Rao Kamala ¹, Sowjanya Vadrevu ¹, Malipeddi Haripriya ¹

Affiliations
1 Aditya Pharmacy College, ADB Road, Surampalem, Kakinada, East Godavari District, IN

Abstract

The developed RP- HPLC method allows rapid and precise determinations of Omeprazole and domperidone, the scope of the present work is to expand and optimization of the chromatographic conditions, to develop RPHPLC method. A series of mobile phases were tried, among the various mobile phases as methanol and 0.1% ammonium acetate an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at 1 ml/min. The Linearity and Correlation Coefficient of Omeprazole and Domperidone were found to be 10-50 ug/ml, and 10.10-50.50 ug/ml 0.9996, and 0.998 respectively. The limit of detection for Omeprazole and domperidone was found to be 1.76 and 2.0 and the limit of quantification was found to be 1.87 and 1.48. The method was known to be accurate with the assay method. The % assay was found to be 97 and 98.12. The developed method was showed to a good accuracy and precision. The % RSD is for Omeprazole and Domperidone is 041 and 1.41. The Isocratic elution technique developed for the determination of Omeprazole and domperidone ideally suited for rapid and routine analysis. This method shows that good reproducibility of the results. Furthermore this method was simple, sensitive, and accurate. Degradation studies were done, here the drug stability results were in the range of acceptance criteria 85-115%.

Keywords

Omeprazole, Domperidone, Optimization, Method Validation, RP-HPLC.

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Sathish Kumar Konidala ¹, Adinarayana Penumala ¹, Vinod Kumar Mugada ¹, Govinda Rao Kamala ¹

Affiliations
1 Aditya Institute of Pharmaceutical Scienecs and Research, Surampalem, Kakinada, East Godawary, Andhra Pradesh – 533 437, IN

Abstract

A simple, validated RP-HPLC method for the simultaneous estimation of Paracetamol and Flupirtine maleate in pharmaceutical dosage form was developed and validated. This method was developed by selecting Inertsil, C18, (250 x 4.6mm, 5μ) column as stationary phase and Methanol: O-Phosporic acid (85: 15 v/v) as mobile phase. Flow rate of mobile phase was maintained at 1 ml/min at ambient temperature throughout the experiment. Quantification was achieved with ultraviolet (DAD) detection at 239 nm. The retention times of Paracetamol and Flupirtine maleate were found as 2.78 min and 3.47 min respectively. The detector response was linear in the concentration range of 65-190 μg/ml and 20-60 μg/ml for Paracetamol and Flupirtine maleate respectively, and the regression coefficients found as 0.998 and 0.999 for Paracetamol and Flupirtine maleate respectively. From recovery studies we concluded that the recovery of Paracetamol and Flupirtine maleate has no interference with any excepients in the formulation. This method has been validated according to ICH guidelines and shown to be Specific, Sensitive, Precise, Accurate, Rugged and Robust. Hence, this method can be applied for routine quality control of Paracetamol and Flupirtine maleate in dosage forms as well as in bulk drug.

Keywords

Paracetamol And Flupirtine Maleate, RP-HPLC, Analytical Method Validation, Lupirtine- P Tablets.

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