Asian Journal of Research in Chemistry

Arvind B. Karadi ¹, S. Appal Raju ¹, Shobha Manjunath ¹, Venugopal Darak ¹

Affiliations
1 Department of Pharmaceutical Analysis, HKES’s College of Pharmacy, Sedam Road, Gulbarga, Karnataka-585105, IN

Abstract

Three simple, sensitive spectrophotometric methods (Method A, B and C) are developed based on the diazotization of Cefditoren Pivoxil with nitrous acid (NaNo₂/HCl) at cold temperature followed by its coupling in-situ with β napthol (Method A) to yield deep purple coloured chromogen, diphenyl amine (Method B) to yield pink coloured chromogen, BMR (Method C) to yield purple coloured chromogen, exhibiting absorption maxima at 542, 506 and 539nm, respectively. Beer's law was obeyed in the concentration ranges of 20-60, 10-50 and 5-30μg/ml respectively. The coloured chromogen was stable for 3-5hrs. These methods were extended to pharmaceutical formulations and there was no interference from any common excepients which are usually present in tablet dosage formulations. The results of analysis have been validated statistically and by recovery studies.

Keywords

Cefditoren Pivoxil, Spectrophotometry, β Napthol, Diphenyl Amine, BMR.

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Arvind B. Karadi ¹, M. Kalpana Jyothi ¹, Ch. Shiva Kumar ¹, S. Appala Raju ¹, Shobha Manjunath ¹, Ashok L. Ganure ²

Affiliations
1 Matoshree Tarabai Rampure Institute of Pharmaceutical Sciences, Gulbarga-585105 (K.S.), IN
2 K.J. College of Pharmacy, Vadasma (North Gujarat), IN

Abstract

A Simple and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of Diacerein in bulk and its pharmaceutical formulations. Chromatographic separation was performed by using column XDB C₈ (4.6×150 mm, 5 μm) with a mobile phase comprising of a mixture of phosphate buffer and Acetonitrile (50:50,v/v) and pH adjusted to 3 with orthophosphoric acid, at a flow rate of 0.8 ml/min with detection at 254 nm. Separation was completed in less than 10 min. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, ruggedness and robustness. Linearity of Diacerein was found to be in the range of 10-100 μg/ml and correlation coefficient was found to be 0.999. The retention time of Diacerein was 3.3 min; the separation was performed at an ambient temperature. The limit of Detection and limit of quantitation for Diacerein was found to be 3.6 and 9.95 (S/N ratio). There was no significant difference in the intraday and inter day analysis of Diacerein determined for five different concentrations using this method. The RSD value 0.3% indicates a high precision of the analytical method. The proposed method was simple, sensitive, precise, accurate and useful for routine quality control analysis.

Keywords

Diacerein, RP-HPLC.

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S. Appala Raju ¹, Arvind B. Karadi ¹, Shobha Manjunath ¹

Affiliations
1 HKE’s College of Pharmacy, Gulbarga-585105 (KS), IN

Abstract

Two simple and sensitive spectrophotometric methods (A and B) for the quantitative estimation of cefditoren pivoxil in bulk drug and pharmaceutical preparations. These methods are based on diazotization of cefditoren with nitrous acid followed by coupling in situ with phloroglucinol (method-A), Resorcinol (method-B) to yield orange yellow colored chromogen and exhibits absorption maximum at 462 and 455 nm respectively. Colored chromogens are stable for 4-6 hrs. and obeyed Beer’s law in the concentration range of 20-80 μg/ml. and 10-50 μg/ml. for (method-A and B) respectively. The results of analysis for the two methods have been validated statistically and by recovery studies. The results are comparing with those obtained using UV spectrophotometric method in 0.1 N HCl at 233 nm.

Keywords

Cefditoren, Resocinol, Phloroglucinol, Spectrophotometry.

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