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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 49 M .Pharm. Thesis

stability were processed and analyzed as per the procedure described in sample

preparation section.

¾ The stability samples after relevant period (at room temperature for 20 hrs) were

processed and analyzed.

¾ The mean back-calculated concentration of stability samples were compared with those

of freshly prepared comparison samples.

¾ % mean change as per formula was calculated.

Acceptance criteria:

¾ The back-calculated concentrations of all LQC and HQC samples must be within 85-

115% of their theoretical concentration.

¾ At least 67% QC samples must fall within above-mentioned criteria at each LQC and

HQC levels.

¾ % Mean change must be within ± 15%.

3. Process stability of GBP at 5°C in auto sampler for 76 hrs:

¾ Process stability of analyte was determined at LQC and HQC levels.

Procedure:

¾ Calibration standards and six replicates each of LQC and HQC comparison samples

prepared by spiking with freshly prepared stock solutions were processed and analyzed as

per the procedure described or use the stored samples.

¾ The above QC samples were kept in the auto sampler for relevant period (at 5°C for 76

hrs) to measure the stability of the processed samples in the auto sampler.

¾ Stability samples after relevant period along with calibration standards and six replicates

each of LQC and HQC comparison samples prepared by spiking with freshly prepared

stock solutions or stock solutions with proven stability were processed and analyzed as

per the procedure.

¾ The process stability period was considered between the time of storing of samples in

auto sampler or refrigerator and the time of analysis of last process stability sample.

¾ The mean back-calculated concentration of stability samples with those of freshly

prepared comparison samples was calculated.

¾ % mean change as per formula was calculated.

Acceptance criteria:

¾ The back-calculated concentrations of all LQC and HQC samples must be within 85-

115% of their nominal concentration.

¾ At least 67% of quality control samples must fall within above-mentioned criteria at each

LQC and HQC levels.

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Samsung RT34M Bedienungsanleitung Seite 61