Degradation Analysis Of Lamivudine, Abacavir And Dolutegravir
According to Stability testing of new drug substances and products, a guideline of ICH desires that to clarify the inherent stability characteristics of the active component stress testing was implemented. The aim of this work was to carry out the stress degradation studies on the Lamivudine, Abacavir and Dolutegravir using the proposed method.
Formulation drug products were exposed to thermal stress, oxidative stress, photolytic, hydrolytic stress under acidic medium and basic medium. An ideal stability indicating method, quantifies the standard drug alone and also resolves its degradation products. So described different types of stress used were thermal, oxidation, photolytic, acidic and basic hydrolysis. Some unknown degradant peaks …show more content…
Prepared the sample solution and then analysed the sample, here no degradant peaks were observed, at the retention time (Rt) Lamivudine, Abacavir and Dolutegravir (Figure 12).The degradations percentage of Lamivudine, Abacavir and Dolutegravir were found to be 11.04, 16.65 and 18.24% respectively
Figure 13 A typical UPLC chromatogram of photoytic stressed sample of Lamivudine, Abacavir and Dolutegravir
Conclusion
The proposed RP-UPLC method is accurate, precise, rapid, robust, sensitive and selective for Lamivudine, Abacavir and Dolutegravir. The prescribed method adapted the use of an economical and easily available mobile phase, stationary phase, convenient and easy extraction procedures. It is an excellent method for the quantification of Lamivudine, Abacavir and Dolutegravir in bulk drugs and in their pharmaceutical dosage forms. A stability-indicating RP-UPLC method for the estimation of Lamivudine, Abacavir and Dolutegravir in their solid dosage forms was established and validated in accordance with the ICH guidelines. The peak purity data and forced degradation experiment data confirmed that there was no interference of the peaks of the active ingredients with those of any other degradation products or other additives. For regular analyses of drugs in bulk and in different formulations,described method was useful without any interference of
Formulation drug products were exposed to thermal stress, oxidative stress, photolytic, hydrolytic stress under acidic medium and basic medium. An ideal stability indicating method, quantifies the standard drug alone and also resolves its degradation products. So described different types of stress used were thermal, oxidation, photolytic, acidic and basic hydrolysis. Some unknown degradant peaks …show more content…
Prepared the sample solution and then analysed the sample, here no degradant peaks were observed, at the retention time (Rt) Lamivudine, Abacavir and Dolutegravir (Figure 12).The degradations percentage of Lamivudine, Abacavir and Dolutegravir were found to be 11.04, 16.65 and 18.24% respectively
Figure 13 A typical UPLC chromatogram of photoytic stressed sample of Lamivudine, Abacavir and Dolutegravir
Conclusion
The proposed RP-UPLC method is accurate, precise, rapid, robust, sensitive and selective for Lamivudine, Abacavir and Dolutegravir. The prescribed method adapted the use of an economical and easily available mobile phase, stationary phase, convenient and easy extraction procedures. It is an excellent method for the quantification of Lamivudine, Abacavir and Dolutegravir in bulk drugs and in their pharmaceutical dosage forms. A stability-indicating RP-UPLC method for the estimation of Lamivudine, Abacavir and Dolutegravir in their solid dosage forms was established and validated in accordance with the ICH guidelines. The peak purity data and forced degradation experiment data confirmed that there was no interference of the peaks of the active ingredients with those of any other degradation products or other additives. For regular analyses of drugs in bulk and in different formulations,described method was useful without any interference of