Development and validation of rapid HPLC method for determination of doxofylline in bulk drug and pharmaceutical dosage forms

Abstract A novel, simple and robust high-performance liquid chromatography (HPLC) method was developed and validated for simultaneous determination of xipamide (XIP), triamterene (TRI) and hydrochlorothiazide (HCT) in their bulk powders and dosage forms. Chromatographic separation was carried out in less than two minutes. The separation was performed on a RP C-18 stationary phase with an isocratic elution system consisting of 0.03 mol L−1 orthophosphoric acid (pH 2.3) and acetonitrile (ACN) as the mobile phase in the ratio of 50:50, at 2.0 mL min−1 flow rate at room temperature. Detection was performed at 220 nm. Validation was performed concerning system suitability, limits of detection and quantitation, accuracy, precision, linearity and robustness. Calibration curves were rectilinear over the range of 0.195–100 μg mL−1 for all the drugs studied. Recovery values were 99.9, 99.6 and 99.0 % for XIP, TRI and HCT, respectively. The method was applied to simultaneous determination of the studied analytes in their pharmaceutical dosage forms.

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Validated RP-HPLC Method for the Determination of Ivabradine Hydrochloride in Pharmaceutical Formulation

International Journal of Pharmaceutical Sciences and Drug Research ◽

10.25004/ijpsdr.2017.090505 ◽

2017 ◽

Vol 9 (05) ◽

Author(s):

MD. Muzaffar -ur- Rehman1 ◽

G. Nagamallika

Keyword(s):

Mobile Phase ◽

Dosage Forms ◽

Hplc Method ◽

Pharmaceutical Formulation ◽

Intermediate Precision ◽

Pharmaceutical Dosage Forms ◽

Rp Hplc ◽

Ich Guidelines ◽

Bulk Drug

A simple, rapid, precise, and accurate RP-HPLC method for the estimation of Ivabradine Hydrochloride an anti-anginal agent, both as a bulk drug and in pharmaceutical formulation was developed. The chromatographic separation was achieved on a Thermosil C18 150 × 4.5 mm, 5μm column by using a mobile phase containing a mixture of methanol and phosphate buffer pH 6.5 in the ratio of 65:35 % v/v at a flow rate of 1ml/min and at an ambient temperature. The detection was monitored at a wavelength of 265nm. A clear chromatographic peak was identified with the retention time of 4.36 min and tailing factor of 1.23. The developed method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method shows a good linear relationship with correlation co-efficient of more than 0.992 in the concentration range of 30μg-150μg. The method showed mean % Recovery of 100.4% and %RSD for repeatability and intermediate precision was less than 2%. The proposed method can be used successfully for the quantitative determination of Ivabradine HCL in pharmaceutical dosage forms.

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METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PIOGLITAZONE IN BULK SAMPLES AS WELL AS IN TABLET DOSAGE FORMS BY USING RP -HPL C

INDIAN DRUGS ◽

10.53879/id.53.09.10394 ◽

2016 ◽

Vol 53 (09) ◽

pp. 42-46

Author(s):

M Debnath ◽

◽

A. S. Kumar ◽

V. D. S Ganta

Keyword(s):

Method Development ◽

Dosage Forms ◽

Hplc Method ◽

Uv Detector ◽

Pharmaceutical Dosage Forms ◽

Method Development And Validation ◽

The Mean ◽

Development And Validation ◽

Tablet Dosage

A simple and precise RP‐HPLC method was developed and validated for the determination of pioglitazone hydrochloride in pharmaceutical dosage forms. Chromatography was carried out using Kromosil- C18 ODS column (250 x 4.6 mm; 5 μm), mixture of acetate buffer: methanol (40:60 v/v) as the mobile phase at a flow rate 1.0 mL/min. The analyte was monitored using UV detector at 254 nm. The retention time for pioglitazone HCl was 3.063 min. The proposed method was found linear in the concentration range of 20.0‐70.0 μg/ml with correlation coefficient of r2=0.9999. The developed method has been statistically validated and found simple and accurate. The mean recoveries obtained for pioglitazone HCl were in the range 99.20-101.59%. Due to its simplicity, rapidness, high precision and accuracy of the proposed method it may be used for determining pioglitazone HCl in bulk and dosage forms.

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