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P. Kalai Selvi ¹, T. Venkatachalam ¹, V. Kishor Kumar ¹, K. G. Lalitha ²

Affiliations
1 Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, Madurai-625020, Tamil Nadu, 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.

Keywords

The Proposed Method was Simple, Sensitive, Precise, Accurate and Useful for Routine Quality Control Analysis.

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T. Venkatachalam ¹, V. Kishor Kumar ¹, P. Kalai Selvi ¹, R. Srinivasan ¹, R. Mariammal ², K. G. Lalitha ³

Affiliations
1 JKKMMRF College of Pharmacy, B. Komarapalayam, IN
2 ROVER College of Pharmacy, Perambalur, IN
3 ULTRA College of Pharmacy, Madurai, IN

Abstract

Simple, sensitive, and specific spectrophotometric methods were developed and validated for quantitation of Metoprolol succinate and Hydrochlorthiazide in tablet dosage form. A new analytical method was developed based on the simultaneous estimation of drugs in a binary mixture without previous separation. In simultaneous equation method, Metoprolol succinate and Hydrochlorthiazide were determined by using their absorptivity values at wavelength maxima, viz., 222 nm and 272 nm. The standard deviation value for the different validation parameters was found to be between 0.094 and 1.01 for simultaneous equation method. This method is simple, accurate, rapid, and they require no preliminary separation and can therefore be used for routine analysis of both drugs in quality control laboratories.

Keywords

Spectrophotometric, Metoprolol Succinate, Hydrochlorthiazide, Simultaneous Equation Method.

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T. Venkatachalam ¹, S. Narendiran ¹, P. Kalai Selvi ¹, P. Dheen Kumar ²

Affiliations
1 Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, IN
2 Dept. of Pharmaceutical Chemistry, Maharaji College of Pharmacy, Chennai-600090, Tamil Nadu, IN

Abstract

A simple, precise, accurate and rapid HPLC method has been developed, and validated for the determination of ofloxacin and satranidazole simultaneously, in combined dosage form. Acetonitrile and ammonium di-hydrogen orthophosphate buffer with ph 7.0 (50%:50%)is used as the mobile phase, 300 is the detection wavelength for this study. The applicability of the method for simultaneous determinations of oflaxacin and satranidazole was verified by the determination of these compounds in marketed tablets .Results of the analysis were validated statistically, and by recovery studies (99.43-101.28%). The recovery and RSD values with in limits given in ICH guidelines method developments indicates that the suitability of proposed for the routine determination of the these compounds in tablets .the validation parameters; linearity (r=9999) sensitivity (LOD (1.0-1.5×10^-4), LOQ (3.0-4.5×10^-4) accuracy (99.43-101.28%) and reproducibility were found to satisfactory. The proposed method can be successfully used to determine the drug contents of marketed formulation.

Keywords

RP-HPLC, Oflaxacin, Satranidazole, Validation.

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