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Audumbar Mali ¹, Santosh Jadhav ¹, Rahul Gorad ², Aamer Quazi ², Ritesh Bathe ¹, Manojkumar Patil ¹, Ashpak Tamboli ³

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Pharmaceutics, ASPM’S K. T. Patil College of Pharmacy, Osmanabad-413501, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Simple, precise, economical, fast and reliable two UV methods have been developed for the simultaneous estimation of Cefixime Trihydrate and Ofloxacin in bulk and pharmaceutical dosage form. Method A is Absorbance maxima method, which is based on measurement of absorption at maximum wavelength of 287 nm and 296 nm for Cefixime Trihydrate and Ofloxacin respectively. Method B is area under curve (AUC), in the wavelength range of 265-301 nm for Cefixime Trihydrate and277-320nm for Ofloxacin. Linearity for detector response was observed in the concentration range of 5-25 μg/ml for Cefixime Trihydrate and 5-25 μg/ml for Ofloxacin. The accuracy of the methods was assessed by recovery studies and was found to be 98.83% and 100.12% for Cefixime Trihydrate and 102.71 % and 99.01 % Ofloxacin by using method A and B respectively. The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. The results were validated statistically as per ICH Q2 R1guideline and were found to be satisfactory. The proposed methods were successfully applied for the determination of for Cefixime Trihydrate and Ofloxacin in commercial pharmaceutical dosage form.

Keywords

Cefixime Trihydrate, Ofloxacin, Simultaneous Estimation, Accuracy, Absorbance Maxima Method, Area under Curve.

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Audumbar Mali ¹, Rahul Gorad ², Aamer Quazi ², Ritesh Bathe ¹, Ashpak Tamboli ³

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Pharmaceutics, ASPM’S K. T. Patil College of Pharmacy, Osmanabad-413501, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Simple, novel, fast, accurate and reliable spectrophotometric methods were developed for determination of Pyridoxine HCl in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Dist. water. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 301-319nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Pyridoxine HCl using 5-25μg/ml (r²=0.9966) for second order derivative Area under Curve spectrophotometric method. The proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Pyridoxine HCl in pharmaceutical formulations.

Keywords

Pyridoxine HCI, Second Order Derivative, Area under Curve (AUC), Precision, Accuracy.

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