Ugotavljanje vsebnosti klindamicina v dermalnih izdelkih z enostavnimi analiznimi metodami

Gregorc, Lucija (author), Roškar, Robert (mentor)

Klindamicin je antibiotik, ki se uporablja za zdravljenje bakterijskih okužb. Ima bakteriostatski in blag bakteriocidni učinek. 1 % dermalna raztopina klindamicina se kot galenski izdelek uporablja za zdravljenje aken. Namen magistrske naloge je bila vpeljava enostavne metode, ki se lahko uporablja v lekarnah oziroma galenskih laboratorijih za kontrolo kakovosti oziroma za določanje vsebnosti klindamicinijevega klorida v galenskih zdravilih. Uporabili smo enostavnejši tehniki, UV spektrofotometrijo in titracijsko metodo ter farmakopejsko metodo HPLC kot referenčno metodo. Vse tri metode smo ovrednotili in pokazali, da dajejo zanesljive rezultate ter jih nato uporabili za primerjalno analizo različnih vzorcev, ki so vsebovali klindamicin. V okviru stabilnostne študije smo proučevali ustreznost enostavnih metod. Ugotovili smo, da klindamicinijev klorid ni stabilen v bazičnem mediju pri povišani temperaturi. Ker z metodo titracije koncentracijo klindamicinijevega klorida določamo preko kloridov, nestabilnosti učinkovine nismo zaznali. UV spektrofotometrija pa se je izkazala kot manj natančna za določanje koncentracije klindamicinijevega klorida v primeru večje nestabilnosti učinkovine v primerjavi z referenčno metodo. Obe enostavnejši metodi nista primerni za določanje vsebnosti klindamicinijevega klorida, ko pričakujemo njegovo nestabilnost. Ta je stabilen pri sobni temperaturi v območju pH od 3 do 5 za daljše časovno obdobje. Pri določanju vsebnosti klindamicinijevega klorida v raztopinah dveh različnih standardov z različno čistostjo in v vzorcih, ki smo jih pripravili po recepturi (1 % dermalna raztopina), smo ugotovili primerljivost vseh treh metod. Pri analizi galenskih zdravil, ki so izven roka uporabnosti, smo dobili primerljive rezultate z metodo HPLC in titracijo. Medtem ko so rezultati UV spektrofotometrije odstopali, kar pa je posledica dodatne komponente v vzorcu, ki smo jo potrdili z metodo HPLC. UV metoda ni selektivna in zato tudi ni primerna za analizo vzorcev, kjer so prisotne interference. Z analizo galenskih zdravil treh proizvajalcev, ki so znotraj roka uporabnosti, smo dokazali primerljivost vseh treh metod. Na podlagi rezultatov lahko zaključimo, da metoda HPLC ostaja metoda izbora za določanje vsebnosti klindamicinijevega klorida v dermalnih raztopinah. Uporabo enostavnejših metod pa predlagamo zlasti v kontroli kakovosti izdelave stabilnih dermalnih izdelkov.

• Language: Slovenian
• Keywords: klindamicinijev klorid, dermalna raztopina, HPLC, enostavna metoda
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-137432
• Publication date in RUL: 17.06.2022

Secondary language

• Language: English
• Title: Determination of clindamycin content in dermal products by simple analytical methods

Abstract

Clindamycin is an antibiotic used for the treatment of bacterial infections. It has a bacteriostatic and mild bactericidal effect. Clindamycin topical solution is used to treat acne. The purpose of the work was to introduce a simple method that can be used in pharmacies or galenic laboratories for quality control to determine the content of clindamycin hydrochloride in galenic products. We have developed simpler techniques, UV spectrophotometry and titration method. The pharmacopoeial HPLC method was used as a reference method. All three methods were evaluated and shown to give reliable results and then used for comparative analysis of different samples containing clindamycin. As part of a stability study, we examined the appropriateness of simple methods. Clindamycin hydrochloride was found to be unstable in the alkaline medium at high temperature. Since the concentration of clindamycin hydrochloride is determined via chlorides by the titration method, no instability of the active substance was detected. However, UV spectrophotometry proved to be less accurate for determining the concentration of clindamycin hydrochloride in untsable samples compared to the reference method. Both simpler methods are not suitable for determining of clindamycin hydrochloride content when instability is expected. Clindamycin hydrochloride is stable at room temperature and in the pH range from 3 to 5 for a long period of time. When determining the content of clindamycin hydrochloride in solutions of two different standards with different purity and in samples prepared according to the recipe (1 % topical solution), all three methods showed comparable results. In the analysis of expired galenic products with clindamycin hydrochloride, comparable results were obtained by HPLC and titration. The results of UV spectrophotometry deviated due to an additional component in the sample, which was confirmed by HPLC. The UV method is not selective and therefore also not suitable for the analysis of samples where interferences are present. By analyzing galenic products with clindamycin hydrochloride from three manufacturers that are within the shelf life, we proved the comparability of all three methods. Based on the results, it can be concluded that the HPLC method remains the method of choice for determining the content of clindamycin hydrochloride in topical solutions. We suggest the use of simpler methods in the quality control of stable topical products.

• Keywords: clindamycin hydrochloride, topical solution, HPLC method, simple method