Development and Validation of Novel UV Spectrophotometric Method for the Determination of Ulipristal Acetate in Bulk and Pharmaceutical Dosage Form

Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency. Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm. Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims. Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.

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Development and Validation of a Derivative Spectrophotometric Method for Simultaneous Determination of Simvastatin and Ezetimibe

E-Journal of Chemistry ◽

10.1155/2010/423057 ◽

2010 ◽

Vol 7 (s1) ◽

pp. S197-S202 ◽

Cited By ~ 3

Author(s):

Effat Souri ◽

Masoud Amanlou

Keyword(s):

Simultaneous Determination ◽

Spectrophotometric Method ◽

Dosage Form ◽

Mechanisms Of Action ◽

Dosage Forms ◽

Pharmaceutical Dosage Form ◽

Zero Crossing ◽

First Order ◽

Development And Validation

A combination of simvastatin and ezetimibe with complementary mechanisms of action is used for treating high levels of cholesterol in the blood. The aim of this study was to develop a rapid and sensitive derivative spectrophotometric method for analysis of these drugs in combined dosage forms. A first order derivative spectrophotometric method was developed for simultaneous determination of simvastatin and ezetimibe using zero-crossing technique. The measurements were carried out at 219 and 265 nm for simvastatin and ezetimibe respectively. The described method was found to be linear (r2>0.999) over the range of 2-40 μg/mL for simvastatin in the presence of 10 μg/mL ezetimibe at 219 nm and in the range of 1-20 μg/mL of ezetimibe in the presence of 20 μg/mL of simvastatin at 265 nm. The within-day and between-day precision values for both drugs were less than 3% (CV). Also, good recoveries were obtained with both synthetic mixtures and commercial tablets. The proposed method was successfully applied for simultaneous determination of simvastatin and ezetimibe in a pharmaceutical dosage form without any interference from excipients.

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DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR THE DETERMINATION OF ULIPRISTAL ACETATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2021.v14i4.40631 ◽

2021 ◽

pp. 83-89

Author(s):

SANATHOIBA SINGHA S ◽

SREENIVAS RAO T

Keyword(s):

Dosage Form ◽

Limit Of Detection ◽

Limit Of Quantification ◽

Intermediate Precision ◽

Pharmaceutical Dosage Form ◽

Pharmaceutical Dosage Forms ◽

Ulipristal Acetate ◽

Relative Standard ◽

Development And Validation

Objective: This work makes an attempt to establish a sensitive and accurate method for the development and validation of an analytical method for estimation of ulipristal acetate (UPA) in bulk and pharmaceutical dosage form. Methods: A mixture of 20 mM acetate buffer pH 3.7 and methanol in the ratio of 70:30 (v/v %) was used as the mobile phase. An xBridge™ C18 column (250 mm × 4.6 mm, 5μ) was used for the analysis at a flow rate of 1 ml/min, injection volume of 20 μl, run time of 15 min, and detection wavelength of 309 nm. The repeatability (within-day in triplicates) and intermediate precision (for 2 days) were carried out by six injections and the obtained results within and between the days of trials were expressed as percent relative standard deviation (% RSD). The linearity of the method was determined by the analysis of analyte concentration across a range of 10 μg/ml–60 μg/ml. Results: The % RSD values of precision studies were found to be below the accepted limit of 2%. The method was found to be linear with a correlation coefficient (R2) of 0.98. The method was also found to be accurate and robust with suitable values. Limit of detection (LOD) and limit of quantification (LOQ) of the method were found to be 0.371 μg/ml and 1.23 μg/ml, respectively. Conclusion: The results of analysis prove that this method can be used for the routine determination of UPA in bulk drug and in pharmaceutical dosage forms.

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