Informatics Publishing Limited

A. B. Thomas ¹, S. B. Dighe ¹, L. P. Kothapalli ¹, R. K. Nanda ¹, S. N. Jagdale ¹, A. D. Deshpande ¹

Affiliations
1 Department of Pharmaceutical Chemistry, Pad. Dr. D.Y.Patil Institute Of Pharmaceutical Sciences and Research, Pimpri, Pune-411 018, Maharashtra, IN

Abstract

Three UV spectrophotometric methods have been developed for the simultaneous estimation of Cefpodoxime proxetil (Cef) and Potassium clavulanate (Pot.clav.) in combined tablet dosage forms. The first method involves Q-absorbance ratio method, the sampling wavelengths selected are, 315.0nm (isoabsorptive point) and 233.0 nm (lmax of Cef). The second method is the First order derivative method, the sampling wavelengths selected are 269.0 nm and 240.0 nm for estimation of Cef and Pot.clav. respectively. In both the methods, the linearity range for both Cef and Pot.clav. was in the concentration range of 1.5-50 μg mL^-1. The third method based on ratio derivative spectrophotometry, involves measurement of absorbances at the amplitudes in the first order derivative of the ratio spectra at 246.0 nm and 327.0 nm for Cef and Pot.clav. respectively over the concentration range of 2.5-50 μg mL^-1for both the drugs. The results of the analysis were validated statistically and recovery studies carried out as per ICH guidelines. The developed methods are rapid, precise, accurate, rugged and can be employed for the routine estimation of Cefpodoxime proxetil and Potassium clavulanate in both bulk and tablet dosage form.

Keywords

Cefpodoxime Proxetil, Potassium Clavulanate, Q-Absorbance Ratio Method, First Order Derivative Spectroscopy, Ratio Spectra Derivative Spectrophotometry.

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Vishakha Shingote ¹, S. D. Mankar ¹, S. B. Dighe ¹

Affiliations
1 Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal: Rahta, Dist: Ahmednagar 413737, IN

Abstract

Any pharmaceutical industry's primary goal is to consistently produce products with the required characteristics and quality at a reasonable cost. A method must be developed for the discovery, development, and evaluation of medicines in pharmaceutical formulations. The primary goal of this review paper was to examine the creation and validation of the medicine formulation technique from the beginning. applies to the entire commercial batch of the product. When an analytical approach is used to obtain results for the quality of medicine-related samples, it is critical that the results are accurate. A validation policy is specified in the pharmaceutical industry for how to execute validation, types of validation, and validation policies to meet the requirements of good manufacturing practise (GMP) laws. Validation is critical to the efficient operation of pharmaceutical companies. Stability and validation were undertaken at every stage, from raw material to completed product. The method was appropriately established, and validation parameters were discussed using the example of various substances in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. For the routine and stability analyses, all validation parameters are utilised.

Keywords

Method development, Validation Parameter, Accuracy, System suitability, LOD, LOQ

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