An analytical approach for determination of amoxicillin and potassium clavulanate in pharmaceutical dosage form review

Modern medicines for human use are required to comply with specific standards and regulation set forth by the concerned authorities. The efficacy and safety ofmedicinal products can only be assured by analytical monitoring of its quality. Pharmaceutical analysis is an art and science of determining the concentration of drugconstituents present in marketed formulation. It is considered as an application of procedures necessary to determine and estimate the identity, strength, quality andpurity of drug. Therefore, the quality control laboratory is considered as the backbone of the pharmaceutical industries with ever-increasing need for the developmentof analytical techniques for drug formulation. In the present review a successful attempt was made to focus various analytical methods available to estimation of amoxicillin sodium and potassium clavulanate in bulk as well as in pharmaceutical dosage form.INTRODUCTIONPharmaceutical industries are coming up with new products, which are virtually a combination of different drugs rather than a single drug alone. Because there is a generalized fact that a combination of drugs have a wider range to treat ailments as compared to the single drug component, therefore industries launches its multicomponent formulations to meet the demand of the market. Pharmaceutical analysis, a branch of pharmacy plays the key role in quality control of pharmaceuticals, through rigid check of raw materials, in process quality of product and finished product[1]. Quality of drugs can only be maintained by developing analytical methods with high degree of accuracy and precision and should satisfy all othervalidation parameters[2-4]. Validation of analytical methods is an important and mandatory aspect of their development or utilization and is widely required on support of industrialproduct development and regulation so methods developed and utilized for analytical monitoring of products must be validated[5-8]. Regardless of the various pharmacopeias and reported methods available, development of procedures that is simple, rapid, precise, and economical and gives a clear separation of drugs is barely needed to maintain the quality of pharmaceuticals. It may be a difficult task, but can be achieved by giving a sincere effort[9].Amoxicillin is a member of the penicillin family[10]. The penicillin nucleus consists of a thiazolidine ring connected to a ß-lactam ring to which is attached a side-chain. The side-chain determines most of the pharmacological and antibacterial properties of the penicillin in question[11]. In the case of amoxicillin the benzyl ring in the side chain extends the range of antimicrobial activity into the Gram-negative bacteria. Amoxicillin kills bacteria by interferingwith the synthesis of the bacterial cell wall. As a result the bacterial cell wall is weakened, the cell swells and then ruptures. Amoxicillin is readily hydrolysed by the staphylococcal penicillinase[12,13].Clavulanic acid, produced by the fermentation of Streptomyces clavuligerus, is a beta-lactam structurally related to the penicillins[14]. Clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillinsand cephalosporins[15]. By inactivating beta-lactamase (the bacterial resistance protein), spectrum of activity of amoxicillin is extended by administration with the ß-lactamase inhibitor clavulanic acid, thus clavulanic acid is used in conjunction with amoxicillin for the treatment of bronchitis and urinary tract, skin, and soft tissue infections caused by betalactamase producing organisms.